Graduate Monitoring Engineer

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. 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. 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. Help manage document control, including the review, approval, and distribution of quality records. Assist in risk management activities, ensuring compliance with ISO 14971. Support training initiatives on QMS processes for employees. Participate in supplier quality assessments and performance monitoring. Ensure compliance with regulatory requirements and support regulatory submissions as needed. Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Management, or a related field. Understanding of ISO 13485, FDA 21 CFR Part 820, and medical device regulations (preferred but not essential). Familiarity with document control systems and quality tools (e.g., FMEA, CAPA, Root Cause Analysis) is a plus.