Quality Engineer
4 weeks ago
As a Quality Engineer at Amgen, you will be responsible for providing technical expertise and oversight to ensure the design and development of medical devices meet regulatory requirements.
Key responsibilities include:
- Providing quality technical expertise and oversight to design and development teams
- Ensuring compliance with regulatory requirements, including MDR, ISO 14971, and ICH Q9
- Reviewing and approving design control documentation, including design input documents, risk summary reports, and verification plans
- Participating in design control stage design reviews and technical design reviews
- Representing CPOQ Development Quality and participating in onsite supplier due diligence visits
To be successful in this role, you will need:
- A Doctorate degree or equivalent experience in a relevant field
- 5+ years of quality and manufacturing experience in the biotech or pharmaceutical industry
- Knowledge of quality engineering and/or mechanical engineering principles
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership
- Experience driving decision making by using DAI principles
As a Quality Engineer at Amgen, you will have the opportunity to work on exciting projects and develop your skills in a dynamic and supportive environment.
We offer a comprehensive benefits package, including a retirement and savings plan, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
We also offer a discretionary annual bonus program and stock-based long-term incentives.
Amgen is an Equal Opportunity employer and welcomes applications from diverse candidates.
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