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Quality Assurance Engineer
ŌURAQuality Assurance Engineer responsible for quality management systems in medical device software development. Collaborating across teams to ensure compliance with international regulations and standards.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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
ATS Keywords
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Hard Skills & Tools
Quality Management SystemsISO 13485:2016MDSAP21 CFR 820EU MDR 2017/745ISO 14971IEC 62304IEC 62366-1eQMS softwareregulatory inspections
Soft Skills
leadershipinterpersonal skillscollaborationcommunicationorganizationprioritizationexecutionattention to detailtechnical guidanceproblem-solving