This role is accountable for building, maintaining, and continuously improving a Quality Management System that meets global medical device regulatory requirements. As a Senior Specialist, you will guide QMS development and execution across the organization, ensuring regulatory readiness, audit compliance, and alignment with corporate quality standards.

• 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 ...