Job Description
What You Will Do
- Ensure Quality Management System (QMS) compliance with applicable internal and external regulatory requirements, including site, corporate, FDA, ISO, EU MDR, and country‑specific regulations.
- Develop, implement, and control updates to regional and local quality management system processes aligned with corporate and divisional QMS requirements.
- Support the management and coordination of internal and external audits, including preparation, execution, and follow‑up activities.
- Coordinate and lead Management Review forums in accordance with applicable procedures, including preparation of meeting minutes and follow‑up action items to closure.
- Participate in the development, maintenance, and continuous improvement of quality policies and procedures.
- Review and approve quality compliance documentation, including non‑conformances, corrective and preventive actions, and change controls, as required.
- Manage doc...