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Principal Quality Engineer

Washington D.C., District of Columbia
Start date
Jun 11, 2024

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Engineering, Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time
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Job Details


If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal Quality Engineer


What you will do

Lets do this. Lets change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and companys procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development of final product align with dynamic global regulations and standards.

  • Ensure program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers related to life cycle management of commercial programs.
  • Train and educate key functional partners and management on combination product requirements, standards and regulations
  • Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of commercial programs
  • Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories.
  • Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging.
  • Provide independent design review for other programs
  • Ensure inspection readiness and maintain CE marks for existing combination product devices
  • Conduct investigations, root cause analyses and risk assessments
  • Collaborate cross-functionally and with Senior Management to drive improvements and provide backup support to other Quality focus areas
  • Work in partnership with Combination Product Operations Quality (CPOQ) Leadership to develop business plans that cultivate staff development and support the direction of the business
  • Benchmark with industry regarding quality and compliance models for devices and combination products
  • Train and mentor relevant staff for development and succession planning

What we expect of you

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

Basic Qualifications:

Doctorate degree and 2 years of Quality experience


Masters degree and 4 years of Quality experience


Bachelors degree and 6 years of Quality experience


Associates degree and 10 years of Quality experience


High school diploma / GED and 12 years of Quality experience

Preferred Qualifications:
  • Bachelors or Masters degree in Life sciences, Engineering, or related subject area
  • 7 years of professional experience in Program Management, Operational Excellence, Quality, R&D, and/production
  • Deep medical device/combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects move through design controls
  • Subject matter expert in Risk Management for combination products
  • Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
  • Strong project management skills / ability to lead all aspects of numerous projects simultaneously
  • Deep understanding of cGxP regulations, practices, and trends pertaining to medical device/combination product quality
  • Lean six-sigma greenbelt/blackbelt
  • Demonstrated strong leadership, negotiation and influencing skills along with advanced communication and analytical skills
  • Effective and timely decision making and influencing skills
  • Ability to work effectively in global multi-functional teams and in a highly matrixed team environment
  • Willingness to learn and be persistent
  • Ability to adapt to changing business needs
  • Willing and able to travel up to 20%

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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.

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.


We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks

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