Quality Assurance Engineer at Oura

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles. Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office. 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. We call this role the Quality Assurance Champion. 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. You will lead the cross-functional coordination of our QMS, ensuring that collective workflows, from supplier selection to software validation, align with international standards without sacrificing speed or agility. We are seeking a candidate with a strong personal drive of quality excellence and motivated by the desire to deliver important medical solutions that can improve the lives of millions of people across the globe. Responsibilities: • Develop, implement, and manage QMS processes to ensure compliance with international standards and internal requirements. • Support continuous improvement to the QMS by identifying areas for improvement and engaging in remediation. • Support the timely investigation of complaints, conduct thorough change impact assessments, and manage Corrective and Preventive Actions (CAPAs) to resolution. • Lead the functional configuration and optimization of the eQMS toolset, ensuring workflows are streamlined and the platform evolves to meet scaling business needs. • Develop and deliver training programs to empower Oura teams with a deep understanding of quality requirements and best practices. • Manage supplier control processes to ensure all partners consistently align with Oura’s rigorous quality benchmarks and compliance standards. • Collaborate with Oura’s SaMD feature development teams by providing technical and quality support during the development, testing and deployment of software. • Contribute in the compilation, review and approval of all technical documentation for SaMD development • Support internal and external audits and inspections as a QMS subject matter expert. Requirements: 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. • You can sense and articulate why certain issues demand more diligence to ensure compliance to applicable regulations or standards. Together we will continue to define Oura as a company where you can: • Be productive and do your best work. • Be part of a world-class engineering team following and helping define best practices. • Contribute to a product that improves the lives of millions of people across the globe. • Be happy and have great work-life balance - we work efficiently, remove the fluff and pointless meetings, so that work continues to inspire and motivate you. • Grow on your chosen career path, be it technical, people, managerial or leadership skills, or any mix of those. Location: In this role you can work remotely in Finland as well as from our easy-to-reach Helsinki or Oulu offices. Benefits: 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! What we offer: • 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 If this sound like an opportunity for you, apply as soon as possible but lates on May 17th. Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note: • Our jobs are listed only on the ŌURA Careers page and trusted job boards. • We will never ask for personal information like ID or payment for equipment upfront. • Official offers are sent through Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.