Auditor & Product Expert For Ivd Expert Devices

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 the non-active products area in your field of expertise.
Sterilize and non-sterilize devices, implantable devices such as orthopedic and dental implants, mesh, and instruments, etc.
Experience & Further Qualifications Degree course 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).
Four years of professional experience is a plus, which can be partially substituted by work at TÜV Rheinland.
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.
Working Location/Branch: Barcelona or Madrid.
We can offer you?
Stable job with an open-ended contract.
Training provided by the company.
Salary to be agreed upon.
Annual working day: 1760 effective hours.
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