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Reedsville, Pennsylvania
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Today
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/ medical devices. Hands-
Easy Apply
Third Party, Contract
50 - 60
