Medical Device Risk & Quality Expert
bayoonet Aktiengesellschaft
bayoonet Aktiengesellschaft is looking for a Risk and Quality Management Expert to manage risk analyses and ensure compliance with ISO standards. The role involves interfacing with customers and development teams, along with creating and updating documentation processes. The ideal candidate should have a degree in medical technology or a related field, with extensive experience in risk management and knowledge of regulatory procedures. Proficiency in German and English is essential. #J-18808-Ljbffr bayoonet Aktiengesellschaft
Vacancy posted 5 days ago
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