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Auditor & Product Expert for IVD Expert Devices
hace 2 meses
We are seeking a highly skilled Auditor & Product Expert to join our team at TUV Rheinland. As a Product Specialist/Expert, you will be responsible for evaluating IVD Expert medical products in accordance with European guidelines and standards.
Key Responsibilities- Evaluate IVD Expert medical products to ensure compliance with European guidelines and standards.
- Review technical documentation of selected product groups in the non-active products area in your field of expertise.
- Assess sterilize and non-sterilize devices, implantable devices such as orthopedic and dental implants, mesh, and instruments.
- Degree in Natural Sciences/Biology, Biotechnology, or Biomedical Engineering.
- At least 4 years of professional experience in design & development, production, quality assurance, regulatory affairs, or quality management of medical devices (related to IVD Expert).
- Auditor training in ISO 13485 or ISO 9001 is a plus.
- 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 a driver's license is necessary.
- Stable job with an open-ended contract.
- Training provided by the company.
- Salary to be agreed upon.
- Annual working day: 1760 effective hours.
