We are looking for a new senior member of the Quality Assurance and Regulatory Affairs Team who will contribute to the Thirona mission by ensuring quality and regulatory compliance in the development of medical devices, and related health services

In this role you will (not an exhaustive list):

  • Drive and support continuous improvement activities (e.g., change control, CAPA management, document control, complaints)
  • Provide quality assurance support to R&D teams throughout the software development process
  • Keep Thirona QMS documents up to date with standards/regulations and support in the implementation of QMS processes
  • Support risk management activities in compliance with ISO 14971

Profile & Competences:

  • Higher professional education
  • Minimum of 5 years of relevant QA/RA work experience in the medical device industry
  • Experienced in managing quality management systems conform to ISO13485 and IEC62304
  • Experienced in guiding medical device software teams according to the IEC62304
  • Experienced in submitting medical devices according to the (EU) 2017/745 Medical Device Regulations
  • Experienced in submitting medical devices according to the US - Part 820 of Title 21 of the Code of Federal Regulations (CFR) - Quality System Regulation (QSR)
  • Strong knowledge of risk management conform ISO14971
  • Excellent verbal and written English communication skills (level C1)

    Practical information:

    • Thirona counts +/-50 employees with international backgrounds
    • Office location: Nijmegen
    • 32-40 hours - hybrid working is allowed
    • Part-time can be considered
    • EU passport or work permit in EU is required for this position
    • 25 vacation days, and 8% holiday allowance
    • Flexible pension plan is offered by Thirona, and 8% pension allowance

    Location:

    Nijmegen, the Netherlands

    Why should you choose us?

    • Join a fast-growing company that enables you to grow both professionally and personally
    • Join a company that is making an impact
    • Increase your level of knowledge by working with highly educated and skilled colleagues and exploring training opportunities
    • We  offer a competitive salary and plenty of personal development opportunities
    • We are a friendly and energetic team of professionals
    • We work hard but have fun together
    • What we do matters for society
    • We keep growing and like to see you growing with us

    We'd love to hear from you!

    • Please send your CV and a motivation letter to vacancies@thirona.eu
    • Acquisition for this vacancy is not appreciated.