Quality Engineer

An established international medical device manufacturer is looking to appoint a Quality Engineer to support product development and lifecycle activities within a regulated environment.

This role sits at the intersection of Quality, R&D, and Regulatory Affairs.

You will be responsible for reviewing, maintaining, and improving technical documentation to ensure compliance with EU MDR and a hardware and software medical device projects
.

• Review and assess technical documentation including:
• Design dossiers and design controls
• Verification and validation documentation
• Process and equipment validation
• Biocompatibility, clinical evaluation, and post‑market surveillance
• Ensure compliance with EU MDR (2017/745) to stand against ISO 13485, ISO 14971, IEC 62366, IEC 62304, ISO 10993
• Evaluate documentation for clarity, consistency, and audit readiness for external reviewers
• Support creation and maintenance of quality and technical documentation (labelling, inspection forms, validation plans)
• Maintain documentation throughout the full product lifecycle
• Participate in internal and external audits
• Support responses to notified body and authority questions
• Coordinate and support change management activities and Change Board meetings
• Work closely with R&D, Regulatory Affairs, Production, and Product Management

• Bachelor’s degree in Biomedical Engineering
  , Life Sciences
  , or a related field
• Several years of experience in medical device quality, engineering, or technical documentation
• Strong knowledge of ISO 13485 and EU MDR
• Experience with additional standards and regulations is an advantage
• Structured, detail‑oriented, and comfortable managing multiple priorities