Role: Quality engineer Location: Reedsville, PA (Day 1 Onsite)Job Summary: Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments.Key Responsibilities:
Lead manufacturing quality assessments and process audits.
Drive FPY improvement and defect reduction initiatives.
Review process validation (IQ/OQ/PQ) and risk management activities.
Manage CAPA, nonconformance, and supplier quality issues.
Support FDA, ISO 13485, MDSAP, and regulatory audits
Required Skills:
Manufacturing Quality Engineering.
Process Validation and TMV.
SPC, MSA, and PFMEA.
CAPA and Nonconformance Management.
FDA 21 CFR Part 820, ISO 13485, ISO 14971
Preferred Qualifications:
Bachelor's/Master's degree in Engineering discipline.
8 years of Medical Device Manufacturing Quality experience.
Experience with Class II/III medical devices.
Experience supporting regulatory audits and inspections
