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Senior Quality Engineer, Medical Devices & Compliance

Job in Cambridge, Middlesex County, Massachusetts, 02140, USA
Listing for: Amgen
Full Time position
Listed on 2026-07-25
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
  • Engineering
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 118435 - 140781 USD Yearly USD 118435.00 140781.00 YEAR
Job Description & How to Apply Below

Amgen is seeking a Senior Quality Engineer to provide quality technical expertise and oversight for combination products and related design controls. You will manage design history files, maintain quality documentation, and support regulatory compliance across GMP/GDP processes.

The role requires collaboration with multiple internal teams and may offer telecommute options. The position emphasizes CAPA, V&V oversight, and risk management per ISO 14971, with opportunities to contribute to

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Position Requirements
10+ Years work experience
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