Position Overview
Quality & Regulatory Compliance - Own and maintain the site Quality Management System (QMS) in alignment with:
- FDA QMSR (21 CFR 820 – ISO 13485:2016 aligned)
- ISO 13485 and applicable global regulations
- Monitor and implement regulatory updates (FDA, ISO, international) and translate them into actionable site requirements.
- Ensure QMS documentation is current, effective, and audit-ready.
Audits & Inspections - Lead and host:
- FDA inspections
- ISO / registrar audits
- Customer audits (medical device OEMs)
- Own audit preparation, execution, response, and closure.
- Develop and track CAPAs to ensure root cause effectiveness and prevention of recurrence.
Risk Management & CAPA - Ensure robust risk management practices across:
- Manufacturing processes
- Material changes
- Supplier changes
- Lead invest...