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.
Manag...
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