Senior Quality Engineer

Katalyst Healthcares & Life Sciences

Brooklyn Park, MN

Instant Apply

30+ days ago

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

Numbers & Facts

Location

Brooklyn Park, MN

Skills

Code of Federal Regulationsunmatched
Contract Manufacturingunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Documentationunmatched
Engineeringunmatched
External Auditunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Injection Moldingunmatched
Internal Auditunmatched
Manufacturingunmatched
Manufacturing Assemblyunmatched
Medical Equipmentunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Manufacturingunmatched
Process Validationunmatched
Product/Service Launchunmatched
Quality Engineeringunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Technical Writingunmatched
Writing Skillsunmatched

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