Specialist Design QA

  • Location

    Hoechberg, Germany

  • Sector:

    Quality

  • Salary:

    65,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    21437

  • Published:

    about 1 month ago

  • Expiry date:

    2021-11-21

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.

Kasia.Krasuska@Adaptivelifescience.com

+44 208 133 5376