Auditor & Product Expert For Ivd Expert Devices

hace 2 semanas


Barcelona, España Sdi Digital Group A tiempo completo

Job Description As a Product Specialist / Expert you evaluate IVD Expert medical products in accordance with European guidelines and standards. You are responsible for the review of the technical documentation of selected product groups in non-active products area in your field of expertise Sterilize and non-sterilize devices, Implantable devices as orthopedic and dental implants, mesh and instruments, etc. Experience & Further Qualifications Degree course in Natural Sciences / Biology, Biotechnology, Biomedical Engineering Degree course in Natural Sciences / Biology, Biotechnology, Biomedical Engineering At least 4 years professional experience in design & development, production, quality assurance, regulatory affairs or quality management of medical devices (related to IVD Expert ). Four years of professional experience is a plus, which can be partially substituted by the work at TÜV Rheinland. Auditor training is a plus ISO 13485 or ISO 9001. Knowledge of relevant guidelines, norms, and product specific standards; Fluent in Spanish and English, Portuguese is a plus. Local and international business trips are required (depending on job position focus as Auditor and / or Product Expert 20 to 50% per month) and driver's license. Working Location / Branch : Barcelona or Madrid #J-18808-Ljbffr



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