Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Associate Quality Complaints - Lab

Live

What you will do

Let’s do this! Let’s change the world! The Senior Associate in Quality Assurance at Amgen plays a crucial role in maintaining high-quality standards across the manufacturing processes. They lead audits, address quality issues, develop training materials for QA procedures, and ensure compliance with both internal guidelines and external regulations.

Amgen is seeking a Sr. Associate Quality Complaints – Product Complaints Return Lab, supporting the Product Complaints and Surveillance Team. The Product Complaints and Surveillance team owns and carries out the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Sr. Associate evaluates complaint related return unit samples. Maintains the product complaint laboratory in compliance with Good Laboratory Practices (GLP). Performs work in a manner consistent with GLPs. Executes day to day operations in the product complaint laboratory and ensures the daily workload is completed efficiently and with high quality (e.g. PMs, calibrations, and general servicing).

Key Responsibilities:

• Applies analytical skills to evaluate product complaint return samples using multiple sources of information

• Manages work in accordance with Good Laboratory Practices (GLPs)

• Interprets SOP requirements

• Identifies product quality and safety risk with product complaint return samples

• Provides technical advice on complaint investigations

• Provides subject matter experts assessments (Return Unit Inspections)

• Partners with FPT on return sample evaluations, establishing inspection criteria and inspection method.

• Performs return inspection for complaints

• Supports product security inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Master’s degree OR

Bachelor’s degree and 6 months of Quality experience OR

Associate’s degree and 2 years of Quality experience OR

High school diploma / GED and 4 years of Quality experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry

• Bachelor’s Degree in a Science Field

• Ability to successfully manage workload to timelines

• Familiarity with basic project management tools

• Demonstrated ability to consistently deliver on-time, and high-quality results

• Ability to operate in a matrixed or team environment

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Global Quality Compliance Undergrad Intern

Live

This could be your everyday

Let’s do this. Let’s change the world. During this program, you will be working closely with the quality compliance team to help prepare to prepare the global auditing processes for migration into a new electronic system. You will have the opportunity to immerse yourself in learning drug/combination product/medical device auditing regulations while helping to streamline and simplify processes.

• Assist in Gathering User Requirements
• Help to Develop Workflows
• Redline and Process Procedural Updates
• Establish Standardized Forms, Reports
• Help to Plan and Execute Workshops

Win

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The quality minded individual we seek is detail orientated with these qualifications:

Basic Qualifications

Amgen requires that all individuals applying for a grad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelor’s Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelor’s degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship

Preferred Qualifications

• Degree concentration(s) in life sciences or engineering.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship/co-op that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

careers.amgen.com Please search for Keyword R-170795

#NBMBAA

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Undergrad Co-op - Quality, Manufacturing, Operations and/or Engineering

Live

This could be your everyday

Let’s do this. Let’s change the world. We have multiple Co-Op opportunities available starting on June 2024. During this program, you will work closely with cross-functional teams to develop your professional career. You will participate in projects, activities or any initiative within the manufacturing industry and provide support to team members. You may also seek resources outside the organization as needed.

• Measure and analyze current systems/process performance.
• Improve operational efficiency and productivity within the organization.
• Identify and implement new process across departments/functions.
• Support to maintain detailed project plan and/or issue log, follow-up activities and process performance.
• Participate in continuous improvement initiatives.
• Prepare project justification.
• Other functions may be assigned to support business needs.

Win

Here’s what it takes to Win

We are all different, yet we all use our outstanding contributions to serve patients. The professional individual we seek is a passionate contributor with these qualifications:

Basic Qualifications

Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria:

• Currently enrolled in a Bachelor’s Degree program from an accredited college or university with a 3.00 minimum GPA.
• Pursuing or completed 3 years of study of the Bachelor’s Degree program in; Biomedical, Industrial, Mechanical, Chemical, Electrical, Computer, Software Engineering or Life Science (Chemistry, Biology, Microbiology, Biotechnology, Biochemistry).
• Be enrolled in a Bachelor’s degree program following the potential internship or Co-Op assignment.

Preferred Qualifications

• Availability to complete the program for up to 1 year.
• Bilingual (English / Spanish).
• Teamwork oriented, organized, basic project management skills, ensuring completion and follow up.
• Be involved in extracurricular activities.
• Proficiency in Microsoft Office (Share Point, Power Point, Word and Excel software) with technical writing skills.
• Presentation, interpersonal and communication skills.
• Meet landmarks and deliver high quality results.
• Clear understating of Amgen Values - Visit our site for additional details.

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship/co-op that defies imagination

If you feel like you’re part of something bigger, it's because you are. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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:

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

Job Summary:

The Global Trade Compliance (GTC) Licensing Analyst works with internal stakeholders to assess international business requirements, prepare export license applications, apply appropriate use of license exceptions when available, and assist business partners to navigate export approvals.  They will primarily focus on efforts related to the Export Administration Regulations (EAR), but will also have ability to assist with similar export authorization actions pursuant to the International Traffic in Arms Regulations (ITAR) as necessary.

Primary Job Duties & Responsibilities:

• Review business requirements to identify what export/import authorizations are required in compliance with EAR (or ITAR when applicable).

• Evaluate international trade requests to determine appropriate export approval actions; draft and prepare license applications using OCR EASE Global Trade Management System.

• Adjudicate and document eligible EAR exceptions for specific business transactions.

• Conduct peer reviews to ensure accuracy and completeness of license applications and exception determinations in accordance with regulations and company policies.

• Follow issuance of export approvals.

• Manage export requirements to ensure compliance with authorization approvals and conditions, identify and conduct export license training as needed.

• Assist in the creation and implementation of standard procedures, work instructions and written guidance.

Job Qualifications:

• Bachelor's degree or higher in a related discipline strongly preferred.

• 3-5 years of experience in global trade licensing or related field.

• Previous experience in a similar capacity with a high tech/defense firm with large volumes and licensing agreements preferred.

• Knowledge of EAR licensing requirements and familiarity with license exceptions.

• Familiarity with ITAR is a plus. 

• Able to serve as a resource to others in the resolution of complex problems and issues.

• Able to prioritize when faced with multiple deadlines and workloads; able to make sound and timely business decisions.

• Able to work independently and constructively with limited supervision.

• Strong time management, organization, and program management skills.

• Excellent communication skills, both verbal and written, and strong presentation skills.

• Strong computer skills: familiarity with OCR EASE, SNAP-R, DECCS, and SAP/GTS a plus.

Applicants must be either a U.S. citizen, U.S. national, legal permanent resident, asylee, refugee or must be eligible to apply for and obtain the appropriate export control license from the U.S. Departments of Commerce and State.

Salary Range:

Pay Transparency

The anticipated salary range listed for this role is only an estimate. Actual compensation for successful candidates is carefully determined based on several factors including, but not limited to, location, education/training, work experience, key skills, and type of position.

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

Teledyne Princeton Instruments (TPI) is looking for a trade compliance manager to manage and enhance the trade compliance program for TPI in either Trenton, NJ or Acton, MA.  The position will oversee all EAR-controlled transactions from a trade compliance perspective, including but not limited to guiding the business on licensing requirements, reviewing transactions and related documents for compliance with the U.S. trade compliance regulations, ensuring maintenance of  records as required by regulation and performing training and other trade compliance functions. The role demands high communication and collaboration skills to interact with the various stakeholders of the business including offices in China, Germany, the UK and elsewhere.  The role will report to the  Trade Compliance Manager for the SciCam companies and the general manager of Teledyne Princeton Instruments. 
 

Primary Duties & Responsibilities:

• Oversee all trade compliance activities for the TPI business while participating in the larger trade compliance team across the Digital Imaging segment.
• Review international orders for proper documentation; provide assistance and guidance as necessary, to ensure completeness and/or appropriateness of paperwork to facilitate license and red-flag evaluation.
• Screen transactional documents including end user certificates for military end use and military end users, denied parties, prohibited end uses, red flags check and other concerns to determine licensing needs of transactions.
• Work with business in the gathering of documents in support of the preparation and submission of US export authorizations, as applicable.
• Review requests for demonstrations and determine when authorizations are needed.
• Act as direct operational point of contract on behalf of the Teledyne Corporate or Digital Imaging Trade Compliance management, as needed.
• Conduct visitor reviews and approvals.
• Assist engineers in the jurisdictional and classification analysis of parts whenever necessary.
• Identify training needs and develop and deliver export compliance training based on government regulations, functional  and company requirements.
• Assist in the creation, review and implementation of policies and procedures to ensure company’s proper use and administration of US Government licenses and exceptions.
• Maintain export-related recordkeeping functions for the TPI offices as required by law.
• Participate in conducting internal compliance audits on a periodic basis.
• Stay abreast of current U.S. export regulations, procedures, laws, policies, etc.
• Create and maintain relationships with various functions and offices throughout TPI.

Job Qualifications:

• Bachelor’s Degree in Business or related field (or combination of education and experience).
• 5-7 years of direct experience with the US export laws and regulations, especially the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR).
• Strong Computer Skills: Word, Excel, Outlook, PowerPoint, and SharePoint. Experience in OCR EASE,  and SAP highly beneficial
• Knowledge of OFAC regulations, country-specific sanctions programs and end use restrictions
• Knowledge of the tariff classification and valuation principles and laws preferred
• Technical expertise in export laws & regulations, including classifications, end use checks, sanctions programs, licensing and restricted party screening
• Experience in development and implementation of export compliance procedures
• Excellent analytical and organization skills including ability to collect, structure, analyze and communicate data
• Knowledge of  AES and EEI filing details and requirements beneficial
• Excellent written and verbal communication skills
• Must be able to organize, prioritize, and drive results
• High accuracy and attention to detail are essential requirements for this position
• Capable of multi-tasking and prioritizing with excellent time management skills is required
• Strong interpersonal skills, critical thinking and problem-solving skills

Applicants must be either a U.S. citizen, U.S. national, legal permanent resident, asylee, refugee or must be eligible to apply for and obtain the appropriate export control license from the U.S. Departments of State or Commerce.

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

We empower the best people to help sustain our world. 100% employee-owned. Independence guaranteed.

Company:

Description:

Enjoy working outdoors? Would you like to gain some experience in Forestry? ACRT Pacific is currently seeking energetic entry-level professionals who enjoy working outdoors. This is a full-time opportunity for individuals who are looking to gain some Forestry experience. Our Vegetation Management Inspectors are ideal for professionals with an educational background in forestry, horticulture, arboriculture, biology, environmental studies, conservation, or related disciplines and who would like to gain experience in these fields and line of work.

Contingent at the approval of our clients, our Vegetation Management Inspectors patrol for hazard trees, perform identification, inspection, and evaluation of trees and brush along utility lines. They also assist in the submitting inspection results to clients with recommendations; Plan, direct, and coordinate the activities of assigned tree clearance crews; Discuss and negotiate line-clearance crew access issues; Serve as a liaison between clients, tree crews, and client customers.

Note: This position is designated as a safety-sensitive role.

Duties & Responsibilities:

• The VMI must perform circuit patrols in accordance with the annual VM plan, VM patrol standards and processes.
• The VMI shall identify required tree work along the existing PG&E rights-of- way; prescribing tree work to be performed; document inspection.
• The VMI shall understand the associated scope and ensure their inspection is meeting the appliable standard.
• The VMI will notify property owners/agencies when tree work will occur and will obtain any necessary authorizations from the property owners/agencies to perform the tree work.
• The VMI may act as the VM contact for new business and re-construction work requested by the energy delivery organization.
• The VMI may perform work verification inspections, verifying applicable inspection and tree work completion and quality.
• The VMI may perform investigation and documentation of tree-related outages and attend outage meetings as requested.
• The VMI may be assigned a variety of VM tags. When assigned perform tracking, field checking, prescribing of work, and notifying of customers associated with non-routine locations. These locations may come from Electric Corrective
• (EC/LC) notifications, Gas OCW notifications, Customer Care & Billing (CC&B) cases, or as assigned. The VMI will need to assist in close out CC&B cases in the field after fielding the case.
• The VMI may support emergency response such as directed by OEC, or level one operations, such as dispatching tree crews, field checking sites, first responder and-by agreements.
• The VMI shall independently complete tasks assigned by the supervisor.
• The VMI shall support oversight of vegetation projects, including field operations such as tree assessment, tree trimming, and other work as required.
• The VMI shall participate in Contractor safety and tailboard meetings.
• The VMI shall act as a customer relations representative on behalf of PG&E.
• The VMI shall provide support and coordination between contractors, communities, agencies, first responders, and all other PG&E workgroups and stakeholders that may be involved in the successful completion of the vegetation project.
• The VMI shall ensure compliance with all applicable regulations which may include, but are not limited to: Annual permits, Encroachment permits, Traffic Control Plans, railroad permits, Caltrans permits, and environmental protection measures as documented on Environmental Release to Construction.
• The VMI shall be proficient in electronic devices and documentation proficiency. As assigned, completes electronic and paper- based documentation and reporting.

Basic Responsibility:

• Patrolling distribution or transmission circuits and prescribe work to be performed by PG&E’s tree contractor, ensuring that the clearances prescribed will maintain compliance for a minimum of one calendar year.
• Determining when the next trim is required and whether a trim or removal is necessary, assessing all trees with the potential to strike PG&E facilities for failure likelihood and hazards.
• Patrolling, identifying, and prescribing required tree pruning and tree/brush removal work needed to facilitate completion of electric compliance tags such as 540 tags to meet all regulatory requirements and/or to PG&E Vegetation Management standards and procedures. Notifying property owners of tree pruning and tree/brush removal work to be performed relating to this specification, mapping circuits using PG&E continuity list.
• Managing EC notifications and cases, performing outage investigations and, when necessary, obtaining permits from public agencies, and documenting work in the VMDSR (or other PG&E assigned databases) using a hand-held computer or an iOS compatible mobile device.
• The VMI shall be required to use computers and associated software, enter data into and process data from hand-held devices, as required.
• The VMI shall perform all necessary duties for emergency response in accordance with all safety requirements, laws and regulations, and applicable labor agreements or an iOS compatible mobile device as directed by the supervisor.
• The VMI shall maintain direct contact with PG&E division personnel, public agencies, and customers as directed by the PG&E representative.
• Knows and exemplifies ACRT’s Guiding Principles.
• Other duties as required.

Equipment, Environmental and Safety Requirements:

• Driving cars, trucks, forklifts, and other equipment
• Walking on uneven ground
• Exposure to excessive noise
• Exposure to extremes in temperature, humidity, or wetness
• Operation of foot controls or repetitive foot movement
• Exposure to dust, gas, fumes, and chemicals
• Prolong periods of time sitting (driving/meetings/trainings)
• Various forestry-related equipment, including but not limited to clinometer, range finder, logger’s tape, DBH tape and other safety-related equipment such as hard hat, safety vest, safety glasses, etc.

Qualifications:

Must meet the general requirements below:

• High school diploma or GED AND
• Required to maintain a Class C driver’s license AND must meet one of the experience levels below:

Experience / Education Requirements (must meet one):

• One (1) year of related arboricultural experience, OR
• ISA Certified Arborist, OR
• 2-year or 4-year college degree in a related field AND
• Approval by PG&E Representative

You must reside within 50 miles of Placerville.

Required Skills:

• Ability to identify local trees and knowledge of growth rates.
• Ability to learn and use company- or job-specific software systems.
• Ability to work in rugged terrain and inclement weather.
• Ability to read and follow maps.
• Accountability: accepts personal responsibility for quality and timeliness of work.
• Accuracy and work quality, performs work completely, correctly, and in a professional manner.
• Adaptability and flexibility: meets the changing conditions and situations in work responsibilities.
• Communications: possesses strong verbal and written communication skills and can present ideas in formal and informal situations.
• Creativity: possesses ability to develop and present new ideas and better ways of doing things.
• Dependability: is reliable and has the ability to do required jobs.
• Drive and achievement orientation sets challenging goals for self and willingly puts in extra time and effort in crisis situations.
• Independence: possesses the ability to work independently.
• Interpersonal skills: builds constructive and effective relationships.
• Job knowledge: possesses sufficient skill and knowledge to perform all aspects of the job.
• Positive attitude: displays optimism about the work to be done and demonstrates a positive attitude towards customers, peers, and the company.
• Quantity of work generates adequate amounts of work based on the job requirements.
• Work comparability: performs work that is comparable to other employees with the same length of service in the same position.

Position Title: Vegetation Management Inspector

Alternate Title: VMI

Position Reports to: Operations Manager

Division: Operations

Department: Operations

Compensation: $37.85-$40.19 an hour DOE

FLSA: Non-Exempt

Bargaining Role: Yes

Salary Range Disclaimer

The base salary range represents the low and high end of the Pacific salary range for this position. Actual salaries will vary depending on factors including but not limited to customer contact terms, location,  experience, and performance. Other rewards may include Paid Time Off, 401(k) retirement savings plan with company match, ESOP contributions, medical, dental, and vision insurance, and other region-specific benefits as eligible. 

Salary Range Transparency

For applicants residing in CA, the salary range for this role is from $37.85 to $40.19.

#LI-ACRT

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

Using established processes, collects and process Engineering Change Orders (ECO’s), validates information is presented correctly and processes requests using Teledyne document control tools. Utilizing effective communications, excellent organizational skills and teamwork, processes all company Engineering and Manufacturing documentation. Creates new structures, gathers required information, such as Bills of Materials (BOM’s), drawings, procedures and releases new part numbers. Along with other members of the team, maintains configuration management, revision control and document archives.

Maintains a comprehensive filing system and computer database for all documents to be retained in the document control center. Administers the operation of the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner. Tasks and assignments tend to be general but may involve complex and/or non-routine assignments. Duties are performed under limited supervision.

Essential Duties and Responsibilities:

· Examines documents, such as blueprints, drawings, Engineering Change Orders (ECO’s), and specifications to verify completeness and accuracy of data

· Confers with document originators or engineering liaison personnel to resolve discrepancies and compiles required changes to documents

· Posts changes to computerized or manual control records, releases documents, and notifies affected departments

· Maintains a computer database of all filed documentation that ensures fast retrieval of documents

· Performs clerical typing duties to generate documents as necessary

· Prepares requests for reproduction of documents

· Operates reproduction equipment

· Prepares reports and memorandums

· Tracks drawing reviews and hosts Engineering Change Board meetings

· Maintains Engineering Change Order Log

· Creates Engineering Part Numbers and drawing titles

· Creates Engineering Part Descriptions

· Scans, records and files paper documents into electronic records

· Strictly adheres to corporate standards for information dissemination and security

· Tracks drawing reviews and approvals to ensure they are processed in a timely manner

· Tracks ECO metrics and generate status reports for engineering department KPIs

· Maintains engineering policies and procedures manual

· Creates standard documentation release packages

· Provides training and guidance on document control procedures to other company personnel

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

· High School Diploma or GED required; Associate’s degree in a related field preferred

· 3 or more years of directly related experience in a document control department or environment

· Familiarity with processing Engineering change request/orders

· Familiarity with configuration control, understanding of change management

· Prior document control experience in technology/engineering/manufacturing environments is required

· Must have excellent written and verbal communication skills

· Excellent organizational skills; detail-oriented and proactive in management of projects and tasks

· Proficiency with Microsoft Office Software

· ISO 9000 experience is a plus

· ERP experience is highly preferred, IFS a plus

· SolidWorks experience highly preferred

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

Job Description

General position summary:

The Associate Director, Quality role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the US in compliance with GDP and GMP requirements.  The position will manage the day to day Quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex. 

This Position Reports to: Director, GDP Operational Quality, International QA

Key Accountabilities:

• Serve as the primary contact and have oversight of Distribution and Logistics partners within the US, including:
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes
  • Maintaining KPIs
  • Analyze, resolve, or assist in solving compliance and customer issues.
  • Escalation of issues
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders

Key Responsibilities:

• Maintain QMS within the Vertex Inc.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and Vertex policies and procedures
  • Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
  • Ensure that customers and suppliers are approved
  • Approving any subcontracting activities that may impact GDP.
  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Create/review and approve Standard operating Procedures and other Quality Documents

Minimum qualifications:

Master’s degree and 4-5 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.
• 5+ years’ experience serving in a Quality role.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select

On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid

Company Information

Job Description

General Summary:

The Quality Systems Director provides technical and strategic leadership for quality systems, quality governance, and quality culture for the cell and gene therapy business unit.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Leads and drives improvements to quality governance forums identifying risks and driving overall compliance and quality maturity
• Provides oversight, support, and drives continuous improvement to quality systems such as change control.  Focuses not just on the process, but the content and compliance of the executed records and helps drive maturity throughout the overall organization.   
• Participates in cross-functional projects in Quality expert and leader role
• Collaborate with internally and external business partners across the organization
• Provides strategies and tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: QMS, risk management, change control and governance.
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Material Compliance Associate

Live

What you will do

Let’s do this. Let’s change the world. Amgen is seeking a Material Compliance Associate at our Thousand Oaks, CA, campus. In this vital role, you will be responsible for assisting the Brand Marketers build and monitor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect “live” edits during compliance review and approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process.

• Quality check submissions for review to ensure alignment with internal standards

• Work with agencies and internal staff, including training on next steps and advising on process standards

• Provide administrative support during review meetings, including gathering “live” edits on submission documents

• Assist with Label updates

• Periodically assist on a variety of MAC-related projects

• Run Veeva reports and communicate outputs to cross-functional partners

• Proofreading commercial and training materials produced by the Marketing teams

• Revise documents electronically

Other skills

• Actively listen to and capture comments from meeting stakeholders

• Anticipate edits and work proactively to suggest solutions

• Ability to champion collaboration, work effectively on cross-functional teams, and consistently deliver timely

• Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills

• Critical thinking and problem-solving skills

• Quick learner, proactive, takes initiative

• Able to distinguish an accurate balance between strategic and tactical thinking

• Strong experience with Project Management tools, methodologies, and practices

• Proven ability to manage in a highly fluid, interactive, matrix environment

• Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, and PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats

• Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest, and assemble information to enable relevant business analysis and influence decision-making

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Bachelor’s degree

Or

• Associates degree and 4 years of Marketing Communications Project Management / Copy-Editing experience

Or

• High school diploma, or GED, and 6 years of Marketing Communications Project Management / Copy-Editing experience

Preferred Qualifications:

• Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field or other regulated industries

• Experience in leading the creation of marketing materials from concept to commercialization

• Experience managing the approval process of marketing materials that are produced at high volumes.

• Copy-Editing experience including excellent typing and spelling skills

• Able to proofread materials using Adobe Acrobat Professional

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

SENIOR MANAGER, IN-VITRO DIAGNOSTICS/ PRECISION MEDICINE QUALITY

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will report to the Senior Director, In-Vitro Diagnostics (IVD) and Precision Medicine Quality. The Senior Manager, In-Vitro Diagnostics/ Precision Medicine Quality supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CdX), and Precision Medicine applications to clinical development. This role is responsible for supporting the implementation of an end to end, proactive and risk-based Quality Assurance strategy for IVD, and Precision Medicine, including third-party collaborations.

The In-Vitro Diagnostics/ Precision Medicine Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development. This strategy will ensure that all Amgen’s business procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness. The In-Vitro Diagnostics/ Precision Medicine Quality strategy also ensures that the business develops and manages fit for purpose standards (SOPs and quality agreements). In addition, the strategy will ensure that Amgen’s QMS is continuously improved upon using quality by design, risk assessments, and outputs from the Quality Management System, including analytics showing quality trends and potential continuous improvement opportunities.

Responsibilities

• Develop collaborative partnerships with Research and Development (R&D) to help establish the state of quality and potential areas of quality risk exposure. Contributes to the use of innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs.

• Collaborate with colleagues in a cross-matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations.

• Support the implementation of IVD quality management strategies to ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the European Union.

• Leverages metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.

• Collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution, and support of regulatory filings.

• Maintain up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.

• Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).

• Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of quality management experience OR

Master’s degree and 6 years of quality management experience OR

Bachelor’s degree and 8 years of quality management experience OR

Associate’s degree and 10 years of quality management experience OR

High school diploma / GED and 12 years of quality management experience

Preferred Qualifications:

• At least 3 years of experience in the pharmaceutical/biotech or medical device industry working within quality a quality management system role, or other relevant experience in clinical research that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support.

• An understanding of medical device development and applicable Global Regulations.

• An understanding of Precision Medicine and applicable Global Regulations.

• An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).

• Experience preferred working within research and development of In-vitro Diagnostics.

• Implementation of technology to improve knowledge management across a diverse R&D environment.

• Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.

• Ability to incorporate business and customer feedback into clear, efficient processes using a straightforward language and format.

• Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.

• Innovative thinking, including the application of quality by design principles

• Collaborative worker with an ability to support a high performing team.

• Excellent verbal and written communication skills, including strong business writing abilities and active listening.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Flowserve is a world-leading manufacturer and aftermarket service provider of comprehensive flow control systems. Driven by our Purpose, we are committed to building a more sustainable future to make the world better for everyone. With more than 16,000 employees in more than 50 countries, we combine our global reach with local presence. We support more than 10,000 customers worldwide, creating products to meet the needs of our customers who are supplying energy, fresh water, pharmaceuticals and other essentials to consumers, businesses and governments globally.

Join a company where the people challenge themselves to approach each situation with ingenuity and creativity to help provide our customers with the most innovative flow control products and services. You will be part of a team known for its industry-leading talent, unparalleled portfolio, and unmatched commitment to customer success. Flowserve’s culture promotes recognition and rewards creativity, hard work, and commitment. We invite you to put your talents and career in motion at Flowserve

Supplier Quality Engineer Specialist

Role Summary:

Responsible for driving Supplier Quality Improvements, working directly with suppliers on Supplier/Process Approvals (Audit), Part Qualification (Flowserve Part Approval Process [FPAP]) and Non-Conforming Report (NCR) Resolution to include Containment, Root Cause, Corrective and Preventative Action. Identify trends within accountable Supplier population and where deemed appropriate, engage central Supplier Development Team for further detailed supplier improvement support activity.

Responsibilities:

• Lead the deployment of problem solving and improvement plans with suppliers. 
• Partner with manufacturing sites and Global Quality to analyze data on supplier performance and identify areas of focus. 
• Support in customer complaints / escapes problem solving (RCA/CA).
• Perform verification audits to suppliers to ensure Corrective Action implementation and sustainability (Control Plan).
• Lead process and product audits to suppliers to verify compliance on Flowserve expectations. 
• Facilitate and/or lead PPAP programs as dictated by procurement strategy (preventive) or quality performance (corrective).
• Support the update and maintenance of different Flowserve platforms: AVL, Assessment documentation, SCAR and CAPA registers. 
• Work with a proactive approach to assure Supplier KPIs compliance and reporting (Non-conformances, Rework, Scrap, First Pass Yield, Escapes, Warranties, Corrective Actions).
• Foster Continuous Improvement culture by leading projects associated with suppliers Cost of Poor Quality. 
• Assure safety rules are followed as a moral authority in the suppliers’ facilities. 
• Support maintaining all Quality certifications for the business (ISO 9001:2015, others site specific) as well as external audits (customer or third party).
• Act with an enterprise and collaboration mindset

Requirements:

• Bachelor’s degree in engineering field (manufacturing, industrial, or mechanical)
• 8 years of experience in Supplier Quality Assurance, no leadership experience required.  
• Previous experience in metal-mechanic industries and similar business.
• ISO 9001:2015 Lead Auditor
• Overall knowledge of API, ASME (Section II, V, VIII, IX) standards.
• Skilled in Team Oriented Problem Solving & Corrective Action management (8D, A3).
• Prior experience leading APQP, PPAP, FAI, GD&T, Control Plan (Core Tools)
• Lean Six Sigma Black Belt or Certified Quality Engineer or equivalent.
• Skilled in data analysis and quality KPI performance management.
• Experience in Quality Software Systems 
• Proficient in Microsoft Office
• English bilingual, business conversation.
• Must be able to travel both domestic and international 50% of time. 
• Outgoing proactive mindset and strong collaborative and communication skills  

Flowserve offers competitive pay, annual bonuses, medical benefits on day 1, generous paid vacation time, paid holidays, 401(k) and many other excellent benefits!

The Oshkosh Corporation Vocational segment leverages the power of our people, brands, and strength in technology to improve the safety, cleanliness, and productivity of our communities.  The Vocational segment includes market leading brands McNeilus, Oshkosh S-Series, IMT, Pierce, MAXIMETAL, Oshkosh Airport Products, and Frontline Communications.  Our purpose-built products serve our communities with carefully designed and engineered refuse trucks, front-discharge mixer trucks, fire apparatus, Airport Rescue and Fire Fighting trucks, service vehicles, and command trucks.   Our products are designed to perform under the toughest conditions.

The Associate Supplier Quality Engineer will support the supply chain organization with the planning and execution of processes designed to improve overall supplier performance (quality, delivery, and cost). This role will interface with individual buyers and category managers, departments, and/or segments.

YOUR IMPACT

• Perform component inspections to engineering specifications to validate nonconformance.
• Support Supplier Production Part Approval Process, validate submissions to Engineering requirements.
• Support and maintain standard work procedures as it relates to supply base performance.
• Validate supplier capabilities, capacity, and quality systems using self-audits and on-site audits.
• Address short term performance issues through 8D/SCAR and rapid continuous improvement. 
• Assist with the identification of standard work and process needs by collaborating with stakeholders.
• Apply tools from lean principal methodology to drive continuous improvement efforts related to supply chain performance.
• Coach, mentor, and train suppliers in continuous improvement.
• Lead/participate in launch readiness programs.
• Monitor supplier quality and delivery performance.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in Engineering or Engineering Technology
• Travel up to 25% (local and/or domestic)

STANDOUT QUALIFICATIONS

• Software experience with Jaggaer, Reliance or JDE
• Ability to interpret weld, electrical, and print drawings
• Supply Chain experience within the manufacturing industry
• Strong organizational skills with exceptional follow through and attention to detail
• Strong time-management and prioritization skills, able to multi-task and prioritize competing requirements and meet deadlines
• Ability to work in a fast-paced environment where requirements are constantly changing

Oshkosh is committed to working with and offering reasonable accommodations to job applicants with disabilities. If you need assistance or an accommodation due to a disability for any part of the recruitment process, please contact our reception desk by phone at +1 (920) 502.3009 or our talent acquisition team by email corporatetalentacquisition@oshkoshcorp.com.

Oshkosh Corporation is an Equal Opportunity and Affirmative Action Employer. This company will provide equal opportunity to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Information collected regarding categories as provided by law will in no way affect the decision regarding an employment application.

Oshkosh Corporation will not discharge or in any manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with Oshkosh Corporation's legal duty to furnish information.

Certain positions with Oshkosh Corporation require access to controlled goods and technologies subject to the International Traffic in Arms Regulations or the Export Administration Regulations. Applicants for these positions may need to be "U.S. Persons," as defined in these regulations. Generally, a "U.S. Person" is a U.S. citizen, lawful permanent resident, or an individual who has been admitted as a refugee or granted asylum.