Quality Assurance Engineer

About 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 2.5 million 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.

Job Summary

We are looking for a Medical Device Quality Assurance Engineer to join the Medical Device team at Oura to help us ensure we are compliant with the applicable standards and regulations governing the development of medical device software. Internally we call this role the Quality Assurance Champion.

Key Responsibilities

• Provide oversight for medical device software products through all phases of the development process, risk management, human factors and usability engineering, process development and verification/validation testing, as well as life cycle management during design changes.
• Guide the software development team to define critical safety and performance requirements.
• Lead the compilation, review and approval of all technical documentation for development and risk management documentation, e.g., planning, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures and regulatory requirements.
• Support the timely handling of complaint investigations, change impact assessments, and CAPAs related to the projects under your governance.
• Support continuous improvement to the Quality Management System by identifying areas for improvement and engaging in remediation.
• Collaborate with Oura’s SaMD feature development teams by providing technical and quality support during the development, testing and deployment of software.
• Support internal and external audits and inspections as a subject matter expert.
• Perform a broad variety of tasks in support of the role and responsibilities.

Requirements

• Degree in: Biomedical/Mechanical Engineering or related technical or scientific discipline.
• 3+ years of experience working in a regulated environment under a medical device Quality Management System (21 CFR 820 or ISO 13485:2016).