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Senior Quality Engineer - Remote Eligible; Medical Devices
Remote / Online - Candidates ideally in
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listed on 2026-07-27
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listing for:
BioSpace
Remote/Work from Home
position Listed on 2026-07-27
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Amgen is seeking a Senior Quality Engineer to provide expert quality oversight for combination products and medical devices within COPQ Commercial. You will manage quality systems, CAPA, and change controls, ensuring compliance with FDA and ISO requirements while supporting cross-functional teams.
The role includes leading V&V efforts, maintaining DHF/DTM, and coordinating audits, inspections, and continuous quality improvements across R&D, Regulatory Affairs, QC, and Manufacturing.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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