Specialist Design QA

  • Location

    Hoechberg, Germany

  • Sector:


  • Salary:


  • Contact:

    Rebecca Stevens

  • Job ref:


  • Published:

    about 1 month ago

  • Expiry date:


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.

Your responsibilities:

  • 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.

Experience required:

  • 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