Auditor & Product Expert for Non-active Devices
hace 1 semana
As a Product Specialist/Expert you evaluate Non-Active 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.
- As an Auditor you primarily conduct audits based on the EC Directive 93/42/EEC, the MDR Regulation, the standard EN ISO 13485 and according to international schemes such as MDSAP and TCP. You compile reports and audit documentation.
**Experience & Further Qualifications**:
- Degree course in Natural Sciences/Biology, Biotechnology, Biomedical Engineering
- Degree course in Natural Sciences/Biology, Biotechnology, Biomedical Engineering
- At least 2 years professional experience in design & development, production, quality assurance, regulatory affairs or quality management of medical devices (related to Non-Active Devices).
- 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
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