Senior Quality Engineer

We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing. Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk Management.

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.