Senior Quality Engineer
Katalyst HealthCares & Life Sciences
Job-ID32834640Reference26-01421Summary:We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing.Roles & 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
Vacancy posted 4 days ago
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