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Lead Auditor for Active Medical Devices
vor 4 Monaten
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:
TÜV SÜD Recruiting