- 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
- Manufacturing Quality Engineering.
- Process Validation and TMV.
- SPC, MSA, and PFMEA.
- CAPA and Nonconformance Management.
- FDA 21 CFR Part 820, ISO 13485, ISO 14971
- 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