质量保证工程师

We are looking for a Quality Assurance Engineer to join Oura’s Medical Device team to help us ensure we are compliant with the applicable standards and regulations governing the development of medical device software at Oura. You will bridge the gap between rigorous regulatory compliance and the fast-paced innovation of our Software as a Medical Device (SaMD) development teams. This role demands close collaboration across the organization to ensure all products and processes are strictly aligned with Quality Management System (QMS) standards throughout their lifecycle.

We would love to have you on our team if you have: Degree in: Biomedical/Mechanical Engineering or related technical or scientific discipline. 3+ years of experience working in a regulated environment, managing Quality Management Systems under ISO 13485:2016 and the MDSAP. Working knowledge and application of device regulations (21 CFR 820 and EU MDR 2017/745). Strong background in standards compliance (ISO 13485:2016, ISO 14971, IEC 62304, IEC 62366-1). Familiarity with eQMS software tooling and experience in implementing, validating, and improving digital quality workflows. Direct experience participating in regulatory inspections (e.g., FDA, Notified Body) and conducting or supporting internal/external quality audits. Demonstrate ability to assess and provide technical guidance for software as a medical device (SaMD). Demonstrate strong skills to organize, prioritize, and execute. Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills.

At Oura, we care about you and your wellbeing. Everyone here at Oura has a ring of their own and are continually looking to improve their health and add to our benefits! Competitive Salary, Lunch benefit, Wellness benefit, Flexible working hours, Collaborative, smart teammates, An Oura ring of your own, Personal learning & development program, Wellness Time Off.

ŌURA is a company dedicated to empowering individuals to realize their inner potential through innovative health technology. Our award-winning products help global users deepen their understanding of their readiness, activity, and sleep quality via the Oura Ring and its connected app. We focus on helping people live healthier and happier lives by providing daily insights and practical steps to inspire healthy lifestyles.