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Quality Assurance Auditor and IVD Product Specialist
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Job Overview
We are seeking a dedicated professional to join our team as a Quality Assurance Auditor and IVD Product Specialist. In this role, you will assess In Vitro Diagnostic (IVD) medical products in compliance with European regulations and standards.
Key Responsibilities
- Conduct evaluations of IVD medical devices, ensuring adherence to established guidelines.
- Review and analyze technical documentation for selected product categories within the non-active medical devices sector.
- Work with both sterilized and non-sterilized devices, including orthopedic and dental implants, meshes, and related instruments.
Required Qualifications
- A degree in Natural Sciences, Biology, Biotechnology, or Biomedical Engineering.
- A minimum of four years of professional experience in design, development, production, quality assurance, regulatory affairs, or quality management of medical devices, particularly in the IVD sector.
- Experience at TÜV Rheinland is advantageous and may substitute part of the required experience.
- Auditor training in ISO 13485 or ISO 9001 is preferred.
- Familiarity with relevant guidelines, standards, and product-specific regulations.
- Proficiency in both Spanish and English; knowledge of Portuguese is an asset.
- Willingness to travel for business purposes, with travel requirements ranging from 20% to 50% per month, depending on the focus of the role.
- A valid driver's license is necessary.
What We Offer
- A stable position with a permanent contract.
- Comprehensive training provided by the organization.
- Competitive salary to be discussed.
- An annual workload of 1760 effective hours.
