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Lead Auditor for Active Medical Devices

vor 4 Monaten


Alle JU, Jura, Schweiz TUV SUD Danmark ApS Vollzeit

LEAD AUDITOR FOR ACTIVE MEDICAL DEVICES

AUFGABEN
Conducting Audits at our customer ́s sites, according to ISO 13485 and MDR 2017/745

Project and Process management from customer order request to certification of the products

Conducting and operating unannounced audits

Planning, preparing and postprocessing of Audits, incl. writing of Audit Reports

Evaluation of change requests from our customers regarding their Quality Management Systems and Medical Devices

QUALIFIKATIONEN
Degree in Electrical Engineering, Electronics Engineering (Minimum Bachelor of Science) or similar

Minimum 3-4 years of professional experience with Active Medical Devices either in R&D, Testing, Production, Field Service Engineering at a Medical Devices Manufacturer or supplier

Ideally first experience with Quality Management according to ISO 13485 or Regulatoty Affairs

Professional Experience with IEC 60601 and Electrical Safety

Regulatory knowledge in MDR desired

Very good MS Office Skills

Travelling flexibility ~ 40% national & international

Driver ́s License

Details zur Ausschreibung

BESCHÄFTIGUNGSART:

  • Vollzeit / Unbefristet
    ARBEITSMODELL:
  • Homeoffice
    STANDORT:
  • Alle Standorte
    LAND:
  • Europa
    EINSATZBEREICH:
  • Medizintechnik & Gesundheitswesen
    BERUFSERFAHRUNG:
  • Berufserfahrene mit 35 Jahren Erfahrung
    GESELLSCHAFT:
  • TUV SUD Danmark ApS
    ORGANISATIONSEINHEIT:
  • DENMARK
    KENNZIFFER:
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