Lead Design Quality Engineer – Medical Devices; Regulated
Job in
Andover, Essex County, Massachusetts, 05544, USA
Listed on 2026-07-16
Listing for:
Capgemini
Full Time
position Listed on 2026-07-16
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Capgemini in Andover, MA is seeking a Design Quality Engineer (Contract) to lead design quality across the product lifecycle for regulated medical devices. You will drive design controls, risk management, and SDLC quality in a cross-functional team environment.
The role requires deep experience with DHF/DMR/DHR, regulatory submissions, and audits, including familiarity with 21 CFR 820, ISO 13485, ISO 14971, and IEC 62304.
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