Auditor & Product Expert for Ivd Expert Devices
hace 4 meses
Location- El Prat de Llobregat- Type of contract- Permanent
Full Time- Occupational field- Auditing & Consulting- Job-ID- 5279- 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
- We can we offert you?- Stable job with an open-ended contract.
- Training provided by the company.
- Salary to be agreed
- Annual working day 1760 effective hours
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