Senior Quality Assurance Engineer

<p>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. By providing daily insights and practical steps to inspire healthy lifestyles, we've helped hundreds of thousands of people understand and improve their health.</p><p>For us, 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 work to promote work-life balance and ensure that our team members have what they need to do their best work — both in and out of the office.</p><p>We are looking for an experienced Quality Assurance Engineer to join the team to help us ensure we are compliant with the applicable standards and regulations governing the development of medical device software at Oura. <strong>We call this role the Quality Assurance Champion.</strong> This role will demand close collaboration with software developers to ensure the software is developed, tested and documented to meet defined requirements. 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.</p><p>While being located in Finland is a plus—Oura has offices in Helsinki, Tampere, and Oulu—it is not a requirement.</p><p><strong>Responsibilities:</strong></p><ul> <li>Provide oversight for medical device software products through all phases of the development process, risk management, human factor/usability engineering, process development and verification/validation testing, as well as life cycle management during design changes.</li> <li>Guide the software development team to define critical safety and performance requirements.</li> <li>Lead the compilation, review and approval of all technical documentation for development and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures and regulatory requirements.</li> <li>Support the timely handling of complaint investigations, change impact assessments, nonconformities, and CAPAs related to the projects under your governance.</li> <li>Support continuous improvement to the Quality Management System by identifying areas for improvement and engaging in remediation.</li> <li>Collaborate with Oura product and software developers that have an impact on regulated products by providing technical and quality support during the development, testing and deployment of software.</li> <li>Support internal and external audits and inspections as a subject matter expert.</li> <li>Perform a broad variety of tasks in support of the role and responsibilities.</li> </ul><p><strong>We would love to have you on our team if you:</strong></p><ul> <li>Degree in Biomedical/Mechanical Engineering or related technical or scientific discipline.</li> <li>5+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016).</li> <li>Working knowledge and application of device regulations (21 CFR 820 and EU MDR 2017/745).</li> <li>Strong background in standards compliance (ISO 13485:2016, ISO 62366-1).</li> <li>Expertise in software quality and risk management standards (IEC 62304, ISO 14971).</li> <li>Experience with application of risk analysis tools such as FMEA, Fishbone, etc.</li> <li>Experience with regulatory inspections and interaction with regulatory authorities.</li> <li>Experience with eQMS software (e.g. Trackwise, MasterControl, ETQ, Greenlight Guru).</li> <li>Demonstrate ability to assess and provide technical guidance for software as a medical device (SaMD).</li> <li>Demonstrate strong skills to organize, prioritize, and execute.</li> <li>Must be detail oriented with strong leadership skills and excellent interpersonal, collaboration and communication skills.</li> <li>You can sense and articulate why certain issues demand more diligence to ensure compliance to applicable regulations or standards.</li> </ul><p>Together we will continue to define Oura as a company where you can:</p><ul> <li>Be productive and do your best work.</li> <li>Be part of a world-class engineering team following and helping define best practices.</li> <li>Contribute to a product that improves the lives of millions of people across the globe.</li> <li>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.</li> <li>Grow on your chosen career path, be it technical, people, managerial or leadership skills, or any mix of those.</li> </ul><p><strong>Benefits</strong></p><p>At Oura, we care about you and your wellbeing. Everyone here at Oura has a ring of