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Quality Engineer, Medical Devices — QMS & NPI Leader
Job in
Reno, Washoe County, Nevada, 89550, USA
Listed on 2026-07-16
Listing for:
Resourcing Edge
Full Time
position Listed on 2026-07-16
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
OMEC Medical is seeking a highly motivated Quality Engineer to own end-to-end quality across the medical device lifecycle. You will establish and maintain the QMS, aligning with FDA 21 CFR Part 820, EU MDR, and ISO 13485/14971, IEC 60601-1, and related standards.
The role involves supporting NPI, design transfer, and post-market activities while ensuring product safety and regulatory compliance. Collaboration with R&D, manufacturing, regulatory affairs, and suppliers is essential.
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