Quality engineer (Medical Device Manufacturing Quality experience)

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