Quality engineer

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.

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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