Graduate QMS Engineer

3 weeks ago


Chelmsford, Essex, United Kingdom Arevna Full time

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.


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