[Hiring] Quality Assurance Engineer @Ōura

Role Description

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.

• 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.

Qualifications

• 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.

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

Company Description

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 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.