• 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