Quality Engineer (m/f/d)

A safe workplace in a company that develops, manufactures and distributes medical devices worldwide – making an important contribution to the health of many people Attractive Benefits such as Hansefit, Jobticket, JobRad and Occupational Careers A team that holds together, supports and shares knowledge A thorough introduction so you can quickly find yourself in your tasks

What's in your job? Together with your colleagues, you actively shape the quality of our products and processes so that we can develop high-quality medical devices.

Your duties include:

Cooperation in the further development of our QM system in the R&D sector (including procedures, templates, methods and tools) Creation and maintenance of medical product files according to MDR Ensure that all relevant normative and regulatory requirements for our medical devices are met – incl. Preparation and support of the conformity assessment procedure Project-specific definition of the basic (standards) requirements to be applied Installation and monitoring of the process-compliant documentation of development projects and implementation of reviews Cooperation and implementation of usability and risk management activities Supporting the development department in quality issues and tasks

Successfully completed technical or scientific studies or a comparable qualification with relevant professional experience Experience in quality management according to ISO 13485 and international approval of medical devices Ideal knowledge in risk management (ISO 14971), software (IEC 62304), usability (IEC 62366-1/-2) and medical device safety (IEC 60601-series) Good to very good knowledge of German and English in word and writing Secure handling of MS Office, especially Word and Excel