Quality Engineer

Location:
Munich

Are you ready to take the next step in your Quality career?

Join a pioneering healthcare company at the forefront of innovation in the cardiovascular field, transforming treatment options for patients worldwide.

We’re looking for a passionate Quality Engineer to join our client’s dynamic team. If you're eager to make an impact in a highly innovative environment, we’d love to hear from you!

 Responsibilities:

  • Review documents and records for consistency, correctness, and completeness.
  • Manage and maintain the Document Management System.
  • Create and control training activities for employees regarding new document revisions.
  • Oversee planned employee qualification activities.
  • Collect and review Device History Record (DHR) documents for final product release.
  • Monitor measurement and monitoring equipment according to SOP.
  • Organize calibration and maintenance activities.
  • Conduct regular review and updates of external documents (e.g., standards, legal documents, certificates).
  • Act as the Quality Issue Owner, controlling and maintaining non-conforming processes.
  • Support QA/RA Managers with tasks related to external suppliers, including routine production and validations.
  • Support the creation, follow-up, and finalization of design changes in the change management process.

Requirements and skills:

  • Bachelor’s degree in Medical Engineering or equivalent.
  • Technical apprenticeship/student with relevant work experience or 2+ years of experience in quality engineering for medical devices.
  • Excellent communication skills with internal and external project partners.
  • Fluent in English (German proficiency is a bonus).
  • Knowledge about regulatory requirements for medical devices e.g. MDR, ISO 13485

If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information.
 

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