Quality Assurance Champion

4 days ago

Oulu, North Ostrobothnia, Finland Oura Full time
Benefits and Perks

We believe in supporting our employees' well-being and career growth. Our benefits package includes competitive compensation, flexible working hours, collaborative team environment, and opportunities for professional development.

Key Skills and Qualifications
  • Degree in Biomedical/Mechanical Engineering or a related technical/scientific discipline.
  • 5+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016).
  • Working knowledge and application of device regulations (21 CFR 820 and EU MDR 2017/745).
  • Expertise in software development and risk management standards (IEC 62304, ISO 14971).
  • Experience in applying human factors and usability engineering to medical devices per IEC 62366-1.
  • Experience with application of risk analysis tools (such as FMEA, or Fault Tree Analysis).
  • Experience in conducting clinical evaluations per EU MDR 2017/745.
  • Demonstrate ability to assess and provide technical guidance for software as a medical device (SaMD).

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