Quality Engineer – Medical Device

Key Responsibilities

• Lead manufacturing quality assessments, audits, and remediation.

• Drive FPY improvement, defect reduction, and quality metrics.

• Review IQ/OQ/PQ, TMV, SPC, MSA, PFMEA, and process risk activities.

• Manage CAPA, nonconformance, and supplier quality issues.

• Support FDA, ISO 13485, MDSAP, and regulatory audits.

Required

• 8+ years of medical device manufacturing quality experience.

• Strong Manufacturing Quality Engineering background.

• Experience with Class II/III medical devices.

• Hands-on CAPA, NC, process validation/TMV, SPC, MSA, and PFMEA.

• Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP.

• Engineering degree preferred.