JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

The Opportunity

his position works out of our Scottsdale, AZ location in the Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Quality Manager is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.

What You’ll Work On

• Provide Quality Engineering leadership in direct support of manufacturing.

• Management and development of Quality Engineers, Supervisors, and/or other Quality employees.

• Provide Quality Engineering guidance and leadership to department and organization.

• Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations and applicable quality certification requirements.

• Aggressively identify and manage activities related to adding value to the organization through validation, risk reduction and cost improvement.

• Provide influential peer leadership with partner sites to drive proactive quality improvements.

• Identify Quality Initiatives and lead cross-functional teams to complete them.

• Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.

• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

• Oversee the validation portions of the Quality System

• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.

• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

• Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.

• Support and or implement all Divisional quality validation initiatives as needed/required.

• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree Or an equivalent combination of education and work experience

• Minimum 8 years, Quality or Quality Engineering experience in a regulated industry. 

• Minimum 3 years, supervisory/leadership role.

• Minimum 2 years, demonstrated experience in process improvement

• Demonstrated and impactful strong project management and people leadership skills required.

• Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.

• Preferred : ASQ Certified Quality Engineer preferred.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Job Title

Quality Project Manager

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

The Quality Project Manager will manage the development and implementation process of company's products and services involving departmental or cross-functional teams focused on the delivery of new or existing products.

What You’ll Work On

• Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
• Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Assures project quality by using standard development methodologies and by working with SQA to develop and execute project quality plans.
• Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
• Resolves project issues by working with team members, project customers, and others as appropriate.
• Consults with internal project groups by sharing project management knowledge and assisting or mentoring more junior project leaders in project management processes and techniques.
• Participates in external project management organizations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.
• Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
• Participates in the development of other technical contributors by facilitating training and providing feedback and guidance.
• May lead a project team. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
• Provides technical leadership to business units.
• Exercises judgment independently.
• Plans and organizes project assignments of substantial variety and complexity.
• Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments. Selects methods and techniques to lead a project to completion.
• Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
• Utilize PowerBI for Data Analysis and objectives tracking.

Required Qualifications

• Quality Assurance, Internal Auditing, Quality Compliance Management or related experience
• Comprehensive knowledge of a particular technological field.
• Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
• Is recognized as an expert in work group and across functions.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Preferred Qualifications

• B.S. in Engineering / Business / Operations discipline or equivalent, plus 6+ years of experience in a similar field.
• M.S. in Engineering / Business / Operations discipline or equivalent, plus 4+ years of experience in a similar field.
• Medical Device or Pharmacology background preferred
• Strong experience with Power BI and Data Analytics highly preferred

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

At HCSC, we consider our employees the cornerstone of our business and the foundation to our success. We enable employees to craft their career with curated development plans that set their learning path to a rewarding and fulfilling career.

Come join us and be part of a purpose driven company who is  invested in your future!

Job Summary

JOB REQUIREMENTS:

• High School Diploma or GED.
• CPC Coding Certification/CPC, CCS, CCSP (REQUIRED)
• 2 years medical coding experience (REQUIRED)
• Experience with process management
• PC experience and skills to include Microsoft Office
• Verbal and written communication skills
• Analytical skills
• Ability to travel 20% - 30% of the time in and out of state

PREFERRED JOB REQUIREMENTS:

• Associate or Bachelor’s degree
• CRC
• Medicare/Commercial Insurance experience  or health care setting

We encourage people of all backgrounds and experiences to apply.

Even if you don’t think you are a perfect fit, apply anyway - you might have qualifications we haven’t even thought of yet.

*Sponsorship will not be provided for this role.* 

Are you being referred to one of our roles? If so, ask your connection at HCSC about our Employee Referral process!

HCSC Employment Statement:

HCSC is committed to diversity in the workplace and to providing equal opportunity and affirmative action to employees and applicants. We are an Equal Opportunity Employment / Affirmative Action employer dedicated to workforce diversity and a drug-free and smoke-free workplace. Drug screening and background investigation are required, as allowed by law. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services.  Our worldwide team helps over 3 million companies, more than 1,300 financial institutions and over 600 million cardholders grow with confidence and achieve amazing results.  We are driven by our passion for success and we are proud to deliver best-in-class payment technology and software solutions.  Join our dynamic team and make your mark on the payments technology landscape of tomorrow. 

About Us

Global Payments is a Fortune 500 worldwide payment technology and software company, providing the world’s leading complete commerce ecosystem to businesses of every size. Our unique, connected infrastructure serves every dimension of commerce, carrying billions of transactions every year—safely and seamlessly.

In the UK & I we employ over 500 people across 5 sites and work with over 60k customers including blue chip companies such as The Post Office, Five Guys & Trainline.

About the Role

(12 month fixed term contract)

The purpose of the Regulatory Compliance Officer role is to manage and maintain a regulatory compliance framework, promoting a compliance culture across the business.  This position can be considered as home based, office based and hybrid working arrangements.

• Conduct periodic 2nd line monitoring reviews as detailed in the Compliance Monitoring Programme on a variety of 1st line activities performed by the business to ensure various regulatory requirements are being adhered to

• Contribute to and maintain the compliance monitoring programme

• Create and maintain the Monthly Information pack (reporting) as a result of the monitoring activities completed, this would include summarising how effectively the business units maintain controls and procedures to ensure regulatory standards are met and good customer outcomes are achieved

• Build relationships with key internal departments across the group; this will include when delivering feedback to departments on the results of the monitoring completed. Enhance the reputation of the Compliance function across the business

• Analyse regulatory requirements and group policies and standards and translate these into practical policies for Global Payments and work with functional areas across the business to implement and enforce policies

• Identify and implement regulatory enhancements to the business through the appropriate channels 

• Assist with incident management, and regulatory reporting where rule breaches have occurred

• Develop positive working relationships with auditors

• Ensure all correspondence, websites, marketing material and documents comply with regulatory requirements before providing compliance approval

• Maintain current knowledge of relevant regulatory changes, and recommend improvements where required

• Support the relationship management for all regulators (FCA, PSR, HMRC, NCA etc)

• Provide consultancy to the UK and Ireland business

• Assist and work closely with the Regulatory Compliance team members, provide support where required

About You

• A proven understanding of relevant financial laws, rules and regulations as appropriate to the card acquiring business and the ability to apply them to Global Payments (including AML)

• Financial/Regulatory compliance related qualifications advantageous but not essential

• Experience within a second line function or monitoring function would be advantageous

• Proven excellent written and verbal communication 

• Ability to objectively assess compliance standards within the business and make suitable recommendations

• Sound reasoning and decision making

• Ability to build and maintain positive working relationships

• Demonstrate highest standards of personal integrity and ethical behaviour

• Attention to detail

• Proven excellent IT literacy skills

Global Payments Inc. is an equal opportunity employer.

Global Payments provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex (including pregnancy), national origin, ancestry, age, marital status, sexual orientation, gender identity or expression, disability, veteran status, genetic information or any other basis protected by law. Those applicants requiring reasonable accommodation to the application and/or interview process should notify a representative of the Human Resources Department.

This role is located at our Austin site (on 290 East, near Toll 130). This is a 100% onsite role, not a remote or hybrid role.

Hardware Manufacturing Customer Experience Quality Engineering position

• Develops and applies quality standards in accordance with company and customer requirements. Develops and conducts related tests.
• Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/ or production equipment.
• Develops methods and parameters, project methodology and/ or project proposals.
• Gathers operational and test data and evaluates results.
• Develops and uses procedures.  Prepares documentation for inspection/ testing procedures. Recommends corrective action for procedural, product, or process deficiencies.
• Analyze operational data – extensive analysis (~15% /week as needed) with Excel (Pivot and VLOOKUP) and Power BI; Develop and implement recommendations based on Field NC data analysis.  
• Evaluates work methods, procedures and policies. Tracks progress of qualification status, reviews reliability test results, determines disposition of non-compliant products, reviews and releases qualification packs 
• Utilizes drawings, specifications, industry standards, and sketches, adapting inspection measuring devices and procedures when necessary. Read and interpret technical drawings and specification requirements.
• Reduces qualification cycle time and cost while still meeting quality performance requirements. 
• Responsible for driving Continuous Improvement in the Quality of AMAT’s product portfolio
• Eliminate customer complaints and escalations. Participates in and may lead audits. 
• Work and demonstrate ability to closely lead multi-functional teams including but not limited to: experienced design and development engineers, Quality and Reliability engineers, Supply Chain Management teams, suppliers and technology partners in order to acquire and implement best known methodologies and deliver a better quality and customer experience than in current portfolio.
• Monitor field customer performance of product to identify issues and allow for early investigation and mitigation
• Drive investigation, capture, Root Cause Analysis, Containment, Corrective Action, Process Improvement to prevent issue recurrence, Monitor plans using statistical methods
• Conduct Quality Post-Mortem and document lessons learned reviews from current and older products to prevent recurrence of Quality issues and drive corrective actions into the next generation product portfolio
• Drive customer escalation resolution (root cause analysis, Containment, Corrective Action and Process Improvements following the 8D discipline format) to prevent recurrence of problems
• Drive Design, Quality, Reliability, lessons learned and VoC (Voice of Customer) requirements into new product designs to improve the quality and reliability of new products.
• Conduct Quality Post-Mortem and document lessons learned reviews from current and older products to prevent recurrence of Quality issues and drive corrective actions into the next generation product portfolio.
• Drive customer escalation resolution

Functional Knowledge

• Demonstrates conceptual and practical expertise in own discipline and basic knowledge of related disciplines.
• Microsoft Office applications (Excel proficiency required), Power BI
• Drive investigation 8D/SCAR Root Cause analysis and Corrective Action, Containment, Prevention, Proliferation measures, FMEA, DMAIC, Green Belt Certified or equivalent, Analytical tools (Paretos, Histograms, Ishikawa (Six Elements), Scatter, Control charts, checklists). Prevent recurrence.
• Experience in high volume manufacturing environments
• Proven track record working and managing customer issues and suppliers Key Performance Indicators (KPIs)
• Manage and coordinate customer PPM (Parts per Million) against supplier PPM, supplier problem solving on time, cost recovery and supplier warranty indicators
• Knowledge of Quality systems and measurements, Lean Manufacturing, Advanced Product Quality Planning (APQP), Product Part Approval Process (PPAP), PFMEA, ISO9001, Quality Assurance tools
• Undertake special projects as required
• Lead, Contribute and support continuous improvement activities
• Prepare and present reports at group meetings and internal customers
• Understanding of engineering drawings and manufacturing processes
• Ability to work in a diverse and dynamic environment
• Planning and prioritizing activities
• Good communication and interpersonal skills
• Negotiation and Influencing skills
• Ability to present data effectively
• Problem-solving skills
• Team working skills
• Analytical skills
• Time management
• Understanding of cost and financial impact

Travel:

• 0– 15%

Education

• Bachelor's Degree – Engineering, Computer Science or related Engineering Technology
• Advanced Quality Certifications
• 6 - 8 + Years of Experience job related

Business Expertise

• Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

Leadership

• Acts as a resource for colleagues with less experience; may lead small projects with manageable risks and resource requirements
• Self-motivated individual, Flexible, Adaptable. Optimistic, Self aware, Open to change
• Work mostly with minimal supervision Assertive, resilient and welcomes change and navigates through adversity
• Shows moral courage, openness and honesty in all dealings
• Engages interest and participation of others and has a collaborative approach to working with others
• Lead, support groups of technicians and engineers
• Training skills, provide guidance and coach other team members
• Supports and thrives on company values

Problem Solving

• Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
• Innovative thinking with high level of attention to detail and from original solutions

Impact

• Impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies

Interpersonal Skills

• Explains difficult or sensitive information; works to build consensus

Qualifications

Education:

Skills:

Certifications:

Languages:

Years of Experience:

Work Experience:

Additional Information

Time Type:

Employee Type:

Travel:

Relocation Eligible:

U.S. Salary Range:

The salary offered to a selected candidate will be based on multiple factors including location, hire grade, job-related knowledge, skills, experience, and with consideration of internal equity of our current team members. In addition to a comprehensive benefits package, candidates may be eligible for other forms of compensation such as participation in a bonus and a stock award program, as applicable.

For all sales roles, the posted salary range is the Target Total Cash (TTC) range for the role, which is the sum of base salary and target bonus amount at 100% goal achievement.

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law. 

Trade Compliance Officer Identity and Biometric Solutions

Austin, TX or Pasadena, CA or Reston, VA or Chanhassen, MN or Arlington, VA.

Position Summary

Thales is looking for a Trade Compliance Officer, a subject matter expert in US and Canadian trade compliance, responsible for the development, implementation, documentation, and maintenance of a comprehensive and efficient local trade compliance program for the Identity & Biometric Solutions (IBS) Business Line operations in North America.

Regulatory Compliance Requirements

Must be a U.S. Person as defined in applicable law, or otherwise authorized or eligible for authorization, to access to hardware, software, technology or technical data controlled under the International Traffic in Arms Regulations (ITAR) and/or the Export Administration Regulations (EAR). 

Key Areas of Responsibility

• Oversee, manage, and direct the trade compliance program for IBS’s North American operations.

• Working as the IBS Business Line Trade Compliance Officer, you will be responsible for developing, synthesizing, deploying, and documenting a local trade compliance program (LCP) that is aligned with the IBS-specific implementation of Thales Group, Digital Identity and Security (DIS), and Country trade compliance policies, procedures, and guidance, as applicable to the IBS business operations in North America.

• Provide Trade Compliance expertise, assess risks, and implement all applicable national import and export control regulations.

• Work closely with key stakeholders across IBS (operations, legal, risk management, finance, IT, procurement, logistics, etc.), and the trade compliance network.

• Provide support to the DIS global business unit (GBU) Trade Compliance Officer and DIS IBS business line (BL) Trade Compliance Manager as required.

Minimum Qualifications

• Bachelor’s degree in a related field of study with a minimum of 7 years of specialized experience in US trade compliance (EAR, FTR, OFAC, and Customs Regulations), preferably with a high-technology/avionics/ defense company or government agency that regulates international trade and a sincere interest to learn Canadian export controls & licensing, administration of data & product classification, and sanctions.

• Demonstrated knowledge of U.S. electronic license application programs (SNAP-R, DECCS) and export reporting (ACE)

• Proven ability to independently apply critical thinking skills to sensitive and complex business scenarios to determine compliance risks, assess compliance gaps, and provide efficient solutions that comply with US trade compliance regulations.

• Demonstrated experience to independently perform risk assessment in the context of business operations, gap analysis in the context of process assessment and development, and root cause analysis in the context of auditing and investigation.

• Competency with restricted party screening tools

• Demonstrated communication skills, including proven ability to provide effective trade compliance training and presentations.

If you’re excited about working with Thales, but not meeting the requirements for this position, we encourage you to join our Talent Community!

Special Position Requirements

Schedule: Monday through Friday, core business hours 9 am to 5 pm

Travel: Travel to Thales IBS locations in NORAM up to 10% of the time  

Pay Transparency

The anticipated TTC range for this role is $85,215- $176,985 USD Annual. The Company reserves the right to ultimately pay more or less than the posted range and offer additional benefits and other compensation, depending on circumstances not related to an applicant’s status protected by local, state, or federal law. 

What We Offer

Thales provides an extensive benefits program for all full-time employees working 30 or more hours per week and their eligible dependents, including the following: 

•Elective Health, Dental, Vision, FSA/HSA, Voluntary Life and AD&D, Whole Group Life w/LTC, Critical Illness, Hospital Indemnity, Accident Insurance, Legal Plan, Identity Theft, and Pet Insurance.

•Retirement Savings Plan after 30 days of employment with a company contribution and a match, and with no vesting period. 

•Company paid holidays and Paid Time Off. 

•Company provided Life Insurance, AD&D, Disability, Employee Assistance Plan, and Well-being Program. 

Why Join Us?

Say HI and learn more about working at Thales click here.

#LI-Hybrid

#LI-RG1

Successful applicant must comply with federal contractor vaccine mandate requirements.

Thales champions inclusion and we believe diversity strengthens the fabric of our culture. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

If you need an accommodation or assistance in order to apply for a position with Thales, please contact us at talentacquisition@us.thalesgroup.com.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

MAIN PURPOSE OF ROLE

The Senior Specialist IT Product Security reports to the Cybersecurity Lead, and works closely with the application development and quality control teams, playing a critical role in the software development lifecycle of our web and mobile applications.

As a Senior Specialist IT Product Security, you demonstrate strong analytical, methodical problem-solving and interpersonal skills, and use these skills to design and implement security test plans and automation, and to support our software development from a security perspective.

The core responsibilities of this role include creating and maintaining modular manual and automated security test plans, executing test scripts, interpreting results, and working with engineering teams to help implement solutions.

You will establish a deep understanding of our applications’ functionality and underlying technology, allowing you to assist with defining acceptance criteria in user stories, and ensure security requirements are covered when testing these user stories.

You will also assist in creating and maintaining cybersecurity documentation, and contribute to threat modeling activities and the creation of data-flow diagrams.

MAIN RESPONSIBILITIES

• Implement clearly written manual and automated security tests for web applications and mobile applications
• Execute penetration tests against applications, interpret and document results • Identify security weaknesses in applications, specifying methods and entry points that threat actors may use to exploit vulnerabilities or weaknesses
• Work with development and QC team to define acceptance criteria, identify risks, and plan testing coverage for upcoming features/releases.
• Participate in the development and evolution of Threat Models and Data Flow Diagrams.
• Participate in application production troubleshooting and analysis.

Education Level

• Bachelors Degree (± 16 years) or equivalent work experience Computer science or technical engineering

Experience/Background

Business Experience

• Minimum of 5 years of experience with software testing, automation, and/or cybersecurity
• Minimum of 2 years of technical experience in a regulated industry • Healthcare system experience desirable.
• Experience working in an agile/scrum environment
• Comfortable and adaptable in a fast-paced and informal environment with the ability to respond and react to changing priorities quickly and efficiently

Technical Experience

• Working knowledge of software test scripting and automation
• Knowledge of the software development lifecycle, testing methodologies, and testing tools
• Knowledge of networking concepts and types of networking attacks
• Experience with penetration testing or adversarial emulation
• Familiarity with OWASP Top 10 and Common Vulnerability Enumeration (CVE) • Experience with thread modeling using STRIDE

Software and Environments

• Competent with Microsoft Office
• Familiarity with Azure Devops/Team Foundation Services
• Experience with testing tools from SmartBear and PortSwigger
• Experience with scripting languages such as Javascript, Powershell, and/or Python
• Experience working in cloud environments such as Microsoft Azure
• Familiarity Microsoft development tools (Visual Studio, MSSQL, VB.net, C#)

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As the Staff Quality Auditor you will be supporting / leading assigned internal audits, supplier audits and external audit processes. You will be supporting / leading the compliance gap management activities including regulatory /standards tracking and other compliance management activities.

What You’ll Work On

• Lead/support assigned internal/clinical/supplier audits to maintain timely closure of the audit cycles

• Support Audit Readiness activities for external audits including training staff /guidance in preparation of external audits

• Support compliance gap management activities e.g. compliance risk management- Identifies risks to the business and resolutions to address compliance gaps.

• Strategize and prioritize the compliance gaps and track them to the closure

• Provides guidance to the subject matter experts (SMEs) in closing the compliance gaps

• Assist management of near miss program

• Track regulations and industry standards revisions. Evaluate and communicate the impact of these revisions with the related departments and follow up compliance to these revisions.

• Prepares/ reviews/analyses the metrics data

• Promotes awareness and understanding of quality & compliance within the division. Provide training to the division to increase compliance awareness

• Participate/Manage the compliance initiatives and other assigned projects

Required Qualifications

Bachelors Degree in Technical Field - Science or Engineering or an equivalent combination of education and work experience

Minimum 5 years of experience

Quality Assurance, Internal Auditing, Quality Compliance Management or related experience

Preferred Qualifications

Medical device/pharma experience

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

MAIN PURPOSE OF ROLE

Experience/Background

Experience

Experience Details

• Medical Device / Pharma

Experience

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

The Opportunity

This position works out of our Liberty, SC location in the Cardiac Rhythm Management division.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

We are seeking a high caliber Inspector II, Receiving who will performs inspection and testing of purchased materials, components and products in accordance with policy and procedures.

This role is open for a Second Shift Schedule. Mon-Thurs-5:30pm-3:30am

What You’ll Work On

• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.

• Records inspection and test data as prescribed by written instructions and procedures.

• Operates all associated test and measurement equipment as instructed and as documented in procedures.

• Recommends changes to policies and procedures.

• May prepare and submit change requests.

• Documents non-conformances in Non-Conforming Material Review system.

• Participates in GR&R studies as directed by engineers or technicians.

• Collects data for First Article inspections.

• Performs testing and inspection in accordance with special test requests.

• May train other Inspectors.

• Assists in gathering, analyzing, and trending of data

• Other Duties: Performs work of a miscellaneous nature as required.

• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. .

EDUCATION AND EXPERIENCE YOU’LL BRING

Education:

• High School Diploma / GED OR an equivalent combination of education and work experience

Experience/Background:

• Minimum 2 years Related work experience.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority (Manufacturing roles only)

• Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Our location in Temecula, CA currently has an opportunity for a QC Chemist.

THIS IS AN ON-SITE DAILY POSITION.

The Opportunity

This position works out of our Temecula, CA location in the Abbott Vascular Division.  Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.  Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

MAIN PURPOSE OF ROLE

Support raw material, in-process material, and finished product lot release, stability studies, engineering evaluations, and any relevant investigation by performing required analytical testing under the GMP environment.

MAIN RESPONSIBILITIES

• Performs routine analysis using approved test methods in a timely manner.

• Prioritizes assigned workload to meet the customer’s needs.

• Maintains current status on all training requirements and supports training activities for other laboratory personnel.

• Understands and follows GMP requirements with respect to laboratory operation, testing, results generation, and documentation.

• Carries out change requests/change controls as needed and be able to provide necessary explanations or justifications to the change.

• Recognizes OOS, OOT, and exception events.

• Initiates and conducts investigation under the supervision of senior laboratory staff.

• Carries out method development, validation, verification, and transfer by following established protocols whenever required.

• Prepares technical protocols and reports as needed under general supervision.

• Maintains a safe working environment in accordance with established procedures and requirements.

• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.

• May lead a project team of moderate scope.

• Provides guidance to less experienced staff.

• Acts as a mentor to lower level individual contributors.

• Influence exerted at peer level and occasionally at first levels of management.

• Plans, organizes, and prioritizes own daily work routine to meet established schedule.

• Exercises authority and judgment within defined limits to determine appropriate action.

• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Minimum Experience / Training Required

Education

Bachelors Degree or Masters Degree OR an equivalent combination of education and work experience

Experience/Background

• 2-5+ years of related work experience with a good understanding of specified functional area.
• Working technical knowledge and application of concepts, practices and procedures.
• General understanding of business unit/group function.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Required experience

• Basic knowledge of cGMP and quality system environment
• Experience with wet chemistry, ICP-OES or chromatography (HPLC, GC or GPC)
• Familiar with LIMS

WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

Position Overview

In this role, you will implement strategies and operational improvements for the Volume businesses of Global License Compliance (GLC). Your responsibilities will include coaching the GLC sales personnel, managing third-party organizations, and ensuring the efficient operation of the North American business.

Reporting to the Senior Director of GLC, AMER, you will also develop business processes and strategies to exceed Autodesk GLC's key objectives for its North American Territory Sales. Working collaboratively with the executive staff and key internal stakeholders, you will drive policies and programs in line with the organization's strategic and operational priorities.

Responsbilities:

• Monitor the policies, practices and processes of GLC North America to determine efficiency and effectiveness. Recommend improvements and develops strategies to achieve and deliver improved results. Implement and follow standards as defined by Corporate and Division senior management; escalate exceptions or questionable practices to direct manager or senior management staff. This may include working with various data support teams, legal, PPL, and Corporate Compliance.
• Regularly interact with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
• Manage and lead a team of top accomplished License compliance sales professionals to exceed assigned quotas, ensuring team efficiency and revenue goals are met. Responsible for the hiring, team effectiveness, culture, performance management and skill development of this team.
• Deliver timely and accurate forecasting of the business, within 2% variance, and pipeline management.
• Manage and develop resources (including consultants, vendors and remote workers, which may be in different time zones). This includes selection, mentoring/coaching, performance management and assessment, and rewards and recognition within own team.
• Work on complex issues where analysis of situations or data requires an in-depth knowledge of Autodesk, its licensing models, and industry best practices. Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensure budgets and schedules meet corporate and divisional requirements.
• Lead or sponsor cross functional or intra-divisional projects for Global License Compliance North America, especially projects related to streamlining and/or improving processes and systems.
• Lead the way in working collaboratively with Territory sales teams on account planning activities to ensure the best customer experiences.
• Manage sales KPIs, pipeline and activity metrics (all leading indicators) of team to ensure these are tracking towards achievement of revenue goals, while ensuring that a balance of sales and enforcement activity is maintained.
• Strategically monitor and review long term goals of the program and ensure campaigns are executed within budget and that License Compliance revenue targets are met.
• May make presentations to existing and prospective customers about the benefits of Autodesk software and engage in final stage negotiation with C level customers and be a point of escalation.
• Manage both Direct and Indirect sales motions.
• Manage a complex volume business that may include highly technical lead sources; responsible for prioritizing various lead programs for the team to maximize effectiveness of the business.
• Collaborates on best practices and drives License Compliance strategies with other geographies and functional groups.

Minimum Qualifications

• 10+ years of relevant experience in technical software or SAAS/PAAS sales; 5+ sales leadership experience with track record of creating high-performing teams.
• Sales experience includes track record of success in difficult negotiations with C-level, handling accounts in the enterprise segment, and conflict resolution.
• Experience in effectively managing a complex, volume-based and digital business and comfortable interfacing with stakeholders at all seniority levels.
• Familiarity with technology, licensing models, and business trends in Autodesk target industries.

Preferred Qualifications:

• Experience or knowledge in Cyber security practices or License Compliance industry
• Experience selling in value-based models
• Ability to build relationships at multiple levels
• Self-motivated with the ability to adapt to changing priorities and business initiative

About Autodesk

Welcome to Autodesk! Amazing things are created every day with our software – from the greenest buildings and cleanest cars to the smartest factories and biggest hit movies. We help innovators turn their ideas into reality, transforming not only how things are made, but what can be made.

We take great pride in our culture here at Autodesk – our Culture Code is at the core of everything we do. Our values and ways of working help our people thrive and realize their potential, which leads to even better outcomes for our customers.

When you’re an Autodesker, you can be your whole, authentic self and do meaningful work that helps build a better future for all. Ready to shape the world and your future? Join us!

Benefits

From health and financial benefits to time away and everyday wellness, we give Autodeskers the best, so they can do their best work. Learn more about our benefits in the U.S. by visiting https://benefits.autodesk.com/

Sales Careers

Working in sales at Autodesk allows you to build meaningful relationships with customers while growing your career. Join us and help make a better, more sustainable world. Learn more here: https://www.autodesk.com/careers/sales

Equal Employment Opportunity

At Autodesk, we're building a diverse workplace and an inclusive culture to give more people the chance to imagine, design, and make a better world. Autodesk is proud to be an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, age, sex, sexual orientation, gender, gender identity, national origin, disability, veteran status or any other legally protected characteristic. We also consider for employment all qualified applicants regardless of criminal histories, consistent with applicable law.

Diversity & Belonging

We take pride in cultivating a culture of belonging and an equitable workplace where everyone can thrive. Learn more here: https://www.autodesk.com/company/diversity-and-belonging

Are you an existing contractor or consultant with Autodesk?

Please search for open jobs and apply internally (not on this external site).

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Our location in Houston, TX, currently has an opportunity for a Quality Technician.

WHAT YOU'LL DO:

MAIN PURPOSE OF ROLE

Performs inspection and testing of purchased materials, components and products in accordance with policy and procedures. Assists Supplier Quality Engineering with technical inspection support.

MAIN RESPONSIBILITIES

• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
• Records inspection and test data as prescribed by written instructions and procedures.
• Operates all associated test and measurement equipment as instructed and as documented in procedures.
• Assists in the Development of inspection methods.
• Recommends changes to policies and procedures.
• Documents non-conformances in Non-Conforming Material Review system.
• Assists Quality Engineering in product nonconformance investigations
• Performs testing and inspection in accordance with special test requests.
• May assist in training of operations staff.
• Assists in gathering, analyzing, and trending of data.
• Performs work of a miscellaneous nature as required.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

EDUCATION AND EXPERIENCE YOU’LL BRING:

Education

High School Diploma / GED required and 4+ years related work experience. Associates Degree or technical diploma preferred .

Experience/Background

• 4+ years’ experience in Quality performing inspection.
• Experience with CMMs, optical measurement equipment, hand tools, gages, pressure and force gage testing.
• Training in blueprint reading and experience with inspection sampling techniques.
• Knowledge of FDA, GMP, ISO 13485.
• Good communication and computer skills, including Microsoft Word, Microsoft Excel, database entry, and use of statistical software packages.
• Prior medical device component inspection experience preferred.
• ASQ CMI certification preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Experience working in a broader enterprise/cross-division business environment.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Must be willing to work overtime as required, including weekends
• Ability to maintain regular and predictable attendance.

WHAT WE OFFER :

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives.   As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.  Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Design Assurance Engineer II, you are responsible for responsible for developing and maintaining test methods, design validation and design verification activities for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).  This is an onsite opportunity in Milpitas, Ca.

What You’ll Do

• Provide guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation (e.g. test plans)
• Develop and implement design assurance engineering concepts, principles, and best practices
• Develop software, hardware, and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.
• Participate in development activities, including design reviews, requirements analysis and tracing, defect tracking, and software configuration management.
• Support the risk management activities for software and systems in compliance with ISO 14971 and software risk requirements in IEC 62304.
• Debug Issues and provide appropriate evidence for development team.
• Specify and execute validation testing for test tools utilized in the product verification.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA, ISO Quality System Regulations, and internal Abbott SOPs.
• Develop Test plans, and test cases based upon the product and component level requirements.
• Create test reports to summarize test results and appropriately track and resolve deviations and defects per Abbott SOPs.

Experience You’ll Bring 

Required 

• Bachelors Degree in  Engineering or Technical Field or an equivalent combination of education and work experience
• Masters Degree/Advanced degree preferred
• Minimum 4 years of  technical experience.
• Previous Quality experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
• Advanced computer skills, including gap analysis and report writing skills.
• Prior medical device experience preferred, Six Sigma certification or Lean Manufacturing experience preferred.
• ASQ CQE, CQA certification preferred .
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Preferred

• Minimum of four (4) years of experience in verification, design assurance or quality assurance role supporting medical devices, preferably with FDA Class II/III experience
• In-depth working knowledge of US FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304.
• Experience with supporting notified body and regulatory inspections and audits
• Experience with electromechanical and embedded systems consisting of custom hardware, software, and software of unknown provenance (SOUP).
• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
• Experience with developing test strategy for integration of system components.
• Working knowledge of Agile Software Development methodologies and associated development tools (SCRUM, Jira, Jama) is highly desirable.
• Familiarity with shell scripting and python
• Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
• Knowledgeable about Quality Assurance methodologies related to regression testing, ad hoc testing, functional testing and verification of calculations, user interface testing, and integration testing.
• Skilled in test plan development and root cause failure analysis.
• Strong verbal (including presentation) and written communication skills, especially technical report writing.

Additionally, the ideal candidate will possess the following:

• Ability to work within and influence a cross-functional, matrix R&D organization
• Ability to develop automated testing framework and automated test scripts.
• Excellent analytical and problem-solving skills
• Motivated self-starter with the ability to work independently and collaboratively
• Ability to follow established policies and procedures, create new processes and procedures, and comply with regulatory requirements.
• Ability to recognize problems and recommend/implement solutions.
• Must be comfortable and able to work well in a fast-paced environment. This requires the candidate to be flexible and able to juggle multiple projects at a time.
• Must be hands-on and results-oriented
• Must be a team player, excellent communicator, and comfortable in an entrepreneurial environment.
• Must be positive, energetic, and a strong advocate for product quality.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission:  why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

EP

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.

Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives.   As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.  Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Design Assurance Engineer II, you are responsible for responsible for developing and maintaining test methods, design validation and design verification activities for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).  This is an onsite opportunity in Milpitas, Ca.

What You’ll Do

• Provide guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation (e.g. test plans)
• Develop and implement design assurance engineering concepts, principles, and best practices
• Develop software, hardware, and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.
• Participate in development activities, including design reviews, requirements analysis and tracing, defect tracking, and software configuration management.
• Support the risk management activities for software and systems in compliance with ISO 14971 and software risk requirements in IEC 62304.
• Debug Issues and provide appropriate evidence for development team.
• Specify and execute validation testing for test tools utilized in the product verification.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA, ISO Quality System Regulations, and internal Abbott SOPs.
• Develop Test plans, and test cases based upon the product and component level requirements.
• Create test reports to summarize test results and appropriately track and resolve deviations and defects per Abbott SOPs.

Experience You’ll Bring 

Required 

• Bachelors Degree in  Engineering or Technical Field or an equivalent combination of education and work experience
• Masters Degree/Advanced degree preferred
• Minimum 4 years of  technical experience.
• Previous Quality experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner.
• Advanced computer skills, including gap analysis and report writing skills.
• Prior medical device experience preferred, Six Sigma certification or Lean Manufacturing experience preferred.
• ASQ CQE, CQA certification preferred .
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Preferred

• Minimum of four (4) years of experience in verification, design assurance or quality assurance role supporting medical devices, preferably with FDA Class II/III experience
• In-depth working knowledge of US FDA Quality System Requirements, ISO 13485, ISO 14971, and IEC 62304.
• Experience with supporting notified body and regulatory inspections and audits
• Experience with electromechanical and embedded systems consisting of custom hardware, software, and software of unknown provenance (SOUP).
• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
• Experience with developing test strategy for integration of system components.
• Working knowledge of Agile Software Development methodologies and associated development tools (SCRUM, Jira, Jama) is highly desirable.
• Familiarity with shell scripting and python
• Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.
• Knowledgeable about Quality Assurance methodologies related to regression testing, ad hoc testing, functional testing and verification of calculations, user interface testing, and integration testing.
• Skilled in test plan development and root cause failure analysis.
• Strong verbal (including presentation) and written communication skills, especially technical report writing.

Additionally, the ideal candidate will possess the following:

• Ability to work within and influence a cross-functional, matrix R&D organization
• Ability to develop automated testing framework and automated test scripts.
• Excellent analytical and problem-solving skills
• Motivated self-starter with the ability to work independently and collaboratively
• Ability to follow established policies and procedures, create new processes and procedures, and comply with regulatory requirements.
• Ability to recognize problems and recommend/implement solutions.
• Must be comfortable and able to work well in a fast-paced environment. This requires the candidate to be flexible and able to juggle multiple projects at a time.
• Must be hands-on and results-oriented
• Must be a team player, excellent communicator, and comfortable in an entrepreneurial environment.
• Must be positive, energetic, and a strong advocate for product quality.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission:  why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

EP

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.

Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES:

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

The Staff Supplier Quality Engineer is responsible for driving improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures. 

What You’ll Work On

• Lead project teams of moderate scope for activities related to Supplier Change Notifications
• Assess potential new suppliers for technical, quality and manufacturing capabilities. 
• Provides technical support for the introduction of components from a new supplier. 
• Generates and maintains incoming inspection procedures. 
• Assists in generating component specifications. 
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products. 
• Analyzes incoming material defects. 
• Dispositions and drives corrective action as necessary. 
• Communicates issues to suppliers. 
• Reviews specifications and provides input from component quality and manufacturability perspective. 
• Investigates field failures related to supplier materials. 
• Develop corrective action plan where necessary 
• May supervise Supplier Quality Engineers or technicians. 
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks. 
• Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management. 
• Plans, organizes, and prioritizes own daily work routine to meet established schedule. 
• Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources. 
   

Required Qualifications

• BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
• 8+ years’ Engineering experience and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, ISO 9001
• Solid communication and interpersonal skills
• Advanced computer skills, including statistical/data analysis and report writing skills
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multitasks, prioritizes and meets deadlines in timely manner
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to travel approximately 10%
• Ability to maintain regular and predictable attendance

Preferred Qualifications

• Training and/or Certification to ISO13485
• Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Prior medical device (implantable) manufacturing experience preferred but not necessary.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: