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Auditor & Product Expert for IVD Expert Devices - El Prat de Llobregat, España - TÜV Rheinland
Descripción
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
