NonStop Consulting
Job Opening: IVDR Auditor (Remote, Medical Devices)
Are you an expert in In Vitro Diagnostics Regulation (IVDR) and eager to use your knowledge to help companies comply with the highest quality standards? As an IVDR Auditor, you will play a crucial role in the certification process, supporting businesses in compliance and quality improvement.
This position offers a high level of autonomy and responsibility within a stable, internationally operating organization, with excellent opportunities for professional development.
Your Responsibilities
As an IVDR Auditor, you will be responsible for conducting audits at client sites in accordance with the In Vitro Diagnostics Regulation (IVDR). Acting as an independent auditor, you will assess risks, opportunities, and regulatory compliance. Additionally, you will write detailed reports and support companies in achieving certification.
Your tasks include:
✔ Conducting audits to assess quality and safety processes at client sites
✔ Document review and pre-assessments to ensure efficient audit execution
✔ Reporting findings and providing recommendations for improvement
✔ Collaborating with a lead auditor during the onboarding period, after which you will conduct audits independently
✔ Regular meetings with the operations manager to discuss progress and findings
What We’re Looking For
✅ Education: A university or technical university degree in a relevant field, such as:
-
Medicine, pharmacology, biomedical or bio-engineering
-
Microbiology, biotechnology, biochemistry
-
Health technology, mechanical or electronic engineering
✅ Experience:
-
At least four years of experience in the healthcare sector, with at least two years in quality management
-
Strong knowledge of IVD products and quality regulations is a plus
💡 Additional Preferred Qualifications:
-
Experience in quality management or quality control within the IVD industry
-
Background in production, R&D, or laboratories, working with technologies such as ELISA, PCR, flow cytometry, cell staining, or microscopy
-
Familiarity with auditing, certification processes, and regulatory frameworks in the medical sector
What We Offer
💼 A challenging role with autonomy and real impact
🚗 Company car for client visits
💻 Laptop and phone for an efficient work environment
📅 25 vacation days + 7 additional days off (ATV days)
🏦 Pension plan with a fixed 6% employer contribution
🚴 Participation in a corporate fitness and cycling plan
📈 Comprehensive training and development opportunities
Do you want to play a key role in medical device certification and contribute to quality improvements in the industry? Apply now and become part of a dynamic and growing team! 🚀
