Senior Quality Engineer
Katalyst CRO · Brooklyn Park, MN · 1 mo ago
On-siteQuality AssuranceContract
About the role
We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing.
Responsibilities
- 10+ years of Quality Engineering experience in medical device manufacturing.
- Strong experience with FDA-regulated environments & Quality Systems.
- Hands-on Technology/Product/Process/Manufacturing Transfers.
- Validation experience: IQ/OQ/PQ, TMV & Process Validation.
- FDA-compliant quality documentation.
- PFMEA, Control Plans, Nonconformance & CAPA.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk Management.
- Customer complaint investigations & Root Cause Analysis.
- Manufacturing readiness, NPI & scale-up.
- Strong technical writing and documentation skills.
- Internal/external audit support preferred.
- Injection molding, assembly or contract manufacturing experience is a plus.