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Lead Auditor, Medical Devices (Home-based EU)

Lead Auditor, Medical Devices (Home-based EU)

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Lead Auditor, Medical Devices (Home-based EU)

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