Quality engineer

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