The role
- Independent implementation of audits according to EN ISO 13485, ISO 9001, MDD, MDR and MDSAP
- Careful evaluation of the technical documentation of any of the following: orthopaedic, active devices, active implantable, vascular, IVD
- Independent assurance of the transparent and reliable processing of all customer orders and customer inquiries
- Dedicated Collaboration and independent project work for international customers
- Continuous training in QM-relevant topics within the audit departments
- Careful support for our customers at home and abroad
- Ensuring that projects are processed on time
Requirements
- Successfully completed studies in the scientific-technical or medical-technical field, e.g. B. Medical technology, medicine, physics, chemistry or biology
- At least four years of professional experience in the QM area as well as a high level of competence in the area of quality management systems
- In-depth product knowledge in one of the following fields: orthopaedic, active devices, active implantable, vascular, IVD
- Regulatory knowledge in the preparation and evaluation of the technical documentation of the above device areas.
- Enthusiasm, passion and flexibility with a convincing appearance
- Fluent German and English skills as well as routine use of MS Office applications
- Car driver's license and enjoyment of regular business trips at home and abroad (travel activity approx. 50%)
- Organisational and coordination talent