Specialist Design Assurance
Our client is a breathing specialist, focusing on ventilation, respiratory diagnostics, anesthesia delivery & patient monitoring.
Due to their continuous growth, they now have an opening for a Specialist Design Assurance to take care of the setup, review and maintenance of the Design History File.
- Setup and maintenance of Design History File / Technical File
- Ensure compliance of the medical devices with the requirements of MDD
- Assist in the maintenance of QM relevant standards & guidelines.
- Control the documentation of the Verification & Validation process via Quality Center.
- Bachelors degree in Product Design, Electrical or Mechanical Engineering or relevant experience.
- Experience of working with Medical Device Regulation (EU MDR).
- Experience of working with Quality management Systems in accordance with ISO 13485.
- Previous experience building/maintaining DHF and the Technical File.
Please apply with your CV or contact Kasia Krasuska for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+44 208 133 5376