Job Description
About the Company
Our client is a leading medical device company dedicated to innovation, quality, and patient safety. We specialize in developing cutting-edge medical technologies and are committed to maintaining the highest regulatory and quality standards.
Role Overview
We are seeking a Graduate QMS Engineer to support our Quality Management System (QMS) and ensure compliance with regulatory requirements. This role is ideal for a recent graduate with a background in Biomedical Engineering, Mechanical Engineering, or a related discipline who is eager to develop their career in medical device quality and regulatory affairs.
Key Responsibilities
1. Assist in the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.
2. Support internal and external audits, including document preparation and corrective actions.
3. Work with cross-functional teams to implement CAPAs (Corrective and Preventive Actions) and track progress.
4. Help manage document control, including the review, approval, and distribution of quality records.
5. Assist in risk management activities, ensuring compliance with ISO 14971.
6. Support training initiatives on QMS processes for employees.
7. Participate in supplier quality assessm...