Senior Quality Engineer - Med Device, FDA-Regulated
Listed on 2026-10-13
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
Job Diva, Inc. urgently seeks a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. You will lead quality engineering efforts, manage transfers and validation activities, and ensure compliance with PFMEA, CAPA, and ISO 13485 requirements.
Ideal candidates have extensive experience with IQ/OQ/PQ validation, FDA 21 CFR Part 820, and robust technical writing skills to maintain compliant documentation and support audits.
This posting is for the Senior Quality Engineer
- Med Device, FDA-Regulated role at Katalyst-Health cares-, based in Brooklyn Park, MN, United States.
Full responsibilities and requirements are described in the listing above.
Learn more about the Senior Quality Engineer
- Med Device, FDA-Regulated role in the description above.
We appreciate your interest in this position.
Join Katalyst-Health cares- and contribute to our ongoing work.
Take a moment to read everything above and see whether this role is right for you.
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