Quality Assurance Engineer

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.

• →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.

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.

In this role you can work remotely in Finland as well as from our easy-to-reach Helsinki or Oulu offices.