Senior Quality Engineer

Katalyst HealthCares & Life Sciences

Job Description

Summary:

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

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Vacancy posted 14 days ago

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