Job Description
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 ...