My client, a Global Medical devices' company, are looking for a Senior Quality Engineer
based in Baden-Württemberg.
A great opportunity to join a fast-growing company with a great portfolio of products and clients.
Senior Quality Engineer
Location: Baden Württemberg
Global Medical devices company
- Collaboration in the further development of the QM system for the R&D area (procedures, templates,
- Methods, tools)
- Creation and maintenance of medical device files according to MDR
- Check whether all normative and regulatory requirements relevant for approval are met
- Medical devices have been met, including preparation and support of the
- Conformity assessment procedure
- Project-specific definition of the basic requirements to be applied and
- Standard requirements
- Setting up and monitoring the process-compliant documentation of development projects
- as well as conducting reviews
- Collaboration and implementation of usability and risk management activities
- Collaborating on standards monitoring
- Support of the development department with quality-related tasks and questions
To be considered you need to have
- Eligibility to work in Germany
- Successfully completed technical or scientific studies or many years
- Experience in quality management
- Experience with 13485 Quality management mandatory
- Knowledge of 14971, 62304, 62366 and 60601 is desirable
- German and English fluent
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