Auditor & Product Expert for IVD Expert Devices

hace 4 días


El Prat de Llobregat, Barcelona, España TÜV Rheinland Group A tiempo completo
Job Summary

We are seeking a highly skilled Auditor & Product Expert to join our team at TÜV Rheinland Group. 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, focusing on your area of expertise.
  • Assess sterilize and non-sterilize devices, implantable devices such as orthopedic and dental implants, mesh, and instruments.
Requirements
  • Bachelor's degree in Natural Sciences, Biology, Biotechnology, or Biomedical Engineering.
  • At least 4 years of 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.
  • Fluency in Spanish and English; Portuguese is a plus.
  • Ability to travel locally and internationally for business purposes (up to 50% of the time).
What We Offer
  • Stable employment with an open-ended contract.
  • Professional training and development opportunities.
  • Competitive salary and benefits package.
  • Annual working hours: 1760 effective hours.


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