Total 16 quality assurance control job vacancies in Media, Pennsylvania

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more supplier’s facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Applies a wide range of methods, principles, and practices directly related to quality control/quality assurance fields; statistical analysis, control and sampling, quality data analysis and evaluation to determine contractor compliance.
• Incorporates a thorough and detailed QA knowledge in applying various methods and techniques for investigating, analyzing, and ensuring corrective action on complex quality problems.
• Develops and implements a surveillance plan which begins with clear objectives supported by a master schedule that includes identification of contractor and sub-contractor production needs.
• Performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.

• Responsible for a wide range of technical and quality activities within the Technical/Quality Division of the Directorate
• Responsible for planning, organizing, coordinating, directing, and integrating the work of subordinate staff.
• Manages and directs subordinate technical, quality assurance and administrative personnel.
• Develops, presents, and promulgates recommendations for changes in/enhancements to branch programs to improve customer service and satisfaction.
• Manages studies and special projects regarding and affecting Supplier Operations plans, goals and initiatives.
• Monitors the collection, consolidation and analysis of metrics and data used to inform operating officials regarding the viability, effectiveness, and efficiency of Team programs.
• Identifies and implements initiatives to eliminate or reduce inefficient and/or ineffective work practices and provides technical guidance to subordinates to improve efficiency and productivity.
• Reviews decisions made by subordinates and/or team leads, assuring application of all personnel management programs.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data. Serves as a member of a multi-functional or technical team.
• Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more suppliers facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractors processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractors quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more supplier’s facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Perform duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identify opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more suppliers facilities.
• Ensure contractors comply with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently audit and survey contractors’ processes to ensure customer and contractual requirements are met.
• Investigate and provide data on customer complaints and concerns regarding contractors’ quality performance and processes that impact user satisfaction.
• Provide technical support to Agency team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment plan.
• Identifies opportunities for process improvements through analysis of process measurement data.
• Serves as a member of a multi-functional or technical team. Responsible for implementing the overall Quality Program for a diversity of products and services in support of U.S. Government acquisition at one or more supplier’s facilities.
• Ensures contractor compliance with all requirements related to the design, manufacturing, repair, overhaul, and modernization of a variety of items for contractor and customer activities throughout the world.
• Independently performs audits/surveillance of contractor’s processes to ensure customer and contractual requirements are met.
• Investigates and provides data on customer complaints/concerns regarding contractor’s quality performance and processes which impact user satisfaction.
• Provides technical support to all other DCMA team members, assisting in the analysis of contract related issues to determine the best course of action to support the contractor and customers.

• Analyzes maintenance history for facilities and equipment.
• Establishes maintenance schedules for facilities and equipment.
• Develops and/or updates equipment profiles.
• Records maintenance and repair history.
• Prepares or assists in preparing an annual and/or periodic program reports.
• Attends project maintenance meetings and relay pertinent information.
• Serves as the primary Facilities and Equipment Maintenance System (FEM) operator.
• Provides access and permissions for employees in the FEM system.
• Utilizes the Computerized Maintenance Management Systems (CMMS) to issue and schedule routine and cyclic maintenance, repair and replacement of all equipment and machinery.

Coatesville VA Medical Center is a 42-building campus-style facility which sits on 128 acres and celebrated its 90th anniversary in November 2020. There are 301 inpatient and residential operating beds, and the medical center serves as a VA specialty referral facility for inpatient and residential mental health programs. In terms of inpatient beds, there are medical, psychiatry, and community living center (24-hour nursing care). Additional information can be found on our internet site VA Coatesville Health Care | Veterans Affairs.

• The Director of Quality Improvement is responsible for coordination and leadership in all performance and quality activities (Performance Measurement/Improvement, External Reviews/Accreditation, Risk Management/Peer Review Coordination, Infection Prevention, Patient Safety, Controlled Substance Program).
• This position is dedicated to the pursuit of higher facility-wide performance in each domain of value (quality, satisfaction, efficiency) through application of expertise, influence, management, and leadership.
• Ensures the facility overall performance and quality programs are coherent and consistent with the network and system wide goals and strategic objectives.
• Aligns and integrates a quality performance management system with leadership roles, strategic planning, and organizational culture. Establishes and maintains a quality measurement system which assesses clinical processes and outcomes, and identifies critical incidents, and the risk thereof, and sentinel events for actions.
• Creates a culture and environment that utilizes evidence-based practice as the pathway to improved outcomes and engages leaders and staff in the application of Just Culture principles.
• Supports and actively participates in initiatives such as Systems Redesign/Lean, Patient Centered Care, ICARE, and Cultural Transformation.
• Supports and participates in the engagement and change management of becoming a High Reliability Organization.

• Serves as Supervisor of Contract Administration Activities for DLA Installation Management Operations Susquehanna.
• Oversees documentation of contract services as provided by Host at Mechanicsburg site as well as routine maintenance requirements
• Administering a variety of construction and service contracts including facility improvements, renovations and repairs, and services contracts such as janitorial services, elevator services, fire suppression systems, etc
• Oversees staff assigned to contract administration and observation for facility related projects and to routine and improvement tasks.
• Manages workload, make assignments, manage asset data collection and provide quality control for work performed.
• Manages technical planning and designing for improvements projects associated with facilities to be constructed or modified.

Coatesville VA Medical Center is a 42-building campus-style facility which sits on 128 acres and celebrated its 90th anniversary in November 2020. There are 301 inpatient and residential operating beds, and the medical center serves as a VA specialty referral facility for inpatient and residential mental health programs. In terms of inpatient beds, there are medical, psychiatry, and community living center (24-hour nursing care). Additional information can be found on our internet site VA Coatesville Health Care | Veterans Affairs.

• The Director of Quality Improvement is responsible for coordination and leadership in all performance and quality activities (Performance Measurement/Improvement, External Reviews/Accreditation, Risk Management/Peer Review Coordination, Infection Prevention, Patient Safety, Controlled Substance Program).
• This position is dedicated to the pursuit of higher facility-wide performance in each domain of value (quality, satisfaction, efficiency) through application of expertise, influence, management, and leadership.
• Ensures the facility overall performance and quality programs are coherent and consistent with the network and system wide goals and strategic objectives.
• Aligns and integrates a quality performance management system with leadership roles, strategic planning, and organizational culture. Establishes and maintains a quality measurement system which assesses clinical processes and outcomes, and identifies critical incidents, and the risk thereof, and sentinel events for actions.
• Creates a culture and environment that utilizes evidence-based practice as the pathway to improved outcomes and engages leaders and staff in the application of Just Culture principles.
• Supports and actively participates in initiatives such as Systems Redesign/Lean, Patient Centered Care, ICARE, and Cultural Transformation.
• Supports and participates in the engagement and change management of becoming a High Reliability Organization.

As a Management and Program Analyst you will:

• Analyzes and Evaluate Organizational Management and Administrative Operations.
• Analyze and Evaluates Line Health Care, Health Regulatory, or Human Services Program Operation.
• Provide Technical Advice on Policies and Procedures
• Advise management and program officials on routine aspects of management or program-related policies and procedures
• Develop and Recommend Operational Policies and Procedures
• Review and evaluate established managerial and program policies and procedures to identify any problems.

As a Program Operations Assistant you will:

• Serve as organizational point for the administration and maintenance of several integrated electronic administrative management tracking systems.
• Receive, read, and prepare responses to incoming correspondence as requested based upon content and topic.
• Perform administrative duties for seminars, small work groups, and conferences that involve Center staff.
• Serve as time clerk for the Branch and/or Team and back-up to the official Division timekeeper as needed, and as such is responsible for the electronic processing and transfer of time and attendance records using the CDC/IS mainframe system.
• Receive and answer telephone and personal inquiries from officials within CDC, DHHS, other Federal agencies, members of Congress, state agencies, foreign visitors, and national organizations.

Non-CA Pay Range (Annual):

At Infinera, your base pay is one part of your total compensation package. Your actual base pay will depend on your skills, qualifications, experience, and location. This role may be eligible for equity grants, discretionary bonuses, or commission payments. The amount of these incentives is based on the terms of the Company’s incentive plans, the Company’s financial performance, and/or individual employee job performance.

Infinera also offers paid leave, medical, 

dental, and vision coverage, 401(k), life, and disability insurance and to

eligible employees.

The R&D Quality Director role requires a unique blend of management and hands-on expertise, serving as a vital bridge between Quality and R&D. We are seeking a seasoned professional with over 20 years of industry experience, including substantial exposure to both software and hardware development. The successful candidate will lead a team of three quality managers, closely partnering with R&D to drive continuous improvements in product quality and processes. This pivotal role ensures that quality remains at the forefront of R&D efforts, fostering excellence across the entire organization.

Key Tasks & Responsibilities:

Secure Quality in Products & R&D Programs

• Q target setting and monitoring
• Process tailoring to secure programs have optimum R&D processes in place and adequately supported and deployed
• Installation & execution of Program Quality Plans and use of metrics for monitoring and analysis of process performance
• Q-Gate readiness check; product quality reviews and audits to monitor and foster process adherence

Support R&D Process Management

• Support process management with subject matter expertise on international Q standards (e.g. TL, ISO) and best practices (e.g. left shifting)
• Support the development, assessment and implementation of key R&D product and process performance measures/metrics

Drive Continual Improvement

• Promote proactive key improvement quality practices
• Support product RCA analysis on field issues escalated to R&D
• Manage process improvement projects that are aligned with strategic goals
• Provide training as it relates to driving process improvements

Value add:

• Independent and neutral Q org to secure quality in products and R&D programs
• Seamless e2e Q workflow supported via Global Quality organization

KPIs:

• Customer-perceived KPIs (CFD, Outages…)
• Q KPIs (test execution rate, test pass rate, critical faults…)
• R&D KPIs (code coverage, defect density, code review effectiveness…)
• TL9K Metrics for certified Product Categories

Key interfaces:

• R&D / ProdM / Service Teams
• Global Q Community

Required Experience:

• 15+ years of experience in SW & HW Development
• Proven Q mgmt. approach with expertise on best in class Q practices & methods
• Experienced leadership re cross-functional / international teams
• Certified auditor
• ISO9K, TL9k, CMMI & Agile
• Jira, SFDC

#LI-DW

#LI-Hybrid

Infinera is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Infinera complies with all applicable state and local laws governing nondiscrimination in employment.

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