Job Information
Amgen Principal Quality Engineer in Washington D.C., District Of Columbia
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.
Principal Quality Engineer
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company’s 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.
Responsibilities:
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
Win
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
Or
Master’s degree and 4 years of Quality experience
Or
Bachelor’s degree and 6 years of Quality experience
Or
Associate’s degree and 10 years of Quality experience
Or
High school diploma / GED and 12 years of Quality experience
Preferred Qualifications:
Bachelor’s or Master’s 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%
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.
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.
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.