- Ensure compliance with ISO 13485, GMP, SOPs and medical-device quality requirements.
- Conduct incoming, in-process and final inspections and maintain quality records.
- Handle NCR, CAPA, deviations, customer complaints and root-cause analysis.
- Support process validation, equipment qualification, risk management and change control activities.
- Coordinate with Production, R&D;, Engineering and Regulatory teams to resolve quality issues.
- Participate in internal/customer/regulatory audits and drive continuous quality improvement.