Job title: Quality engineer (Medical Device Manufacturing Quality experience)

Location:

Reedsville, PA (Onsite) Job type: Full time and Contract c2c both

Interview:

Video 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