Graduate QMS 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.

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

• 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.
• Support internal and external audits, including document preparation and corrective actions.
• Work with cross-functional teams to implement CAPAs (Corrective and Preventive Actions) and track progress.
• 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.

Key Skills & Qualifications

• 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).
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication and teamwork abilities.
• Ability to manage multiple tasks and work in a fast-paced environment.
• Familiarity with document control systems and quality tools (e.g., FMEA, CAPA, Root Cause Analysis) is a plus.