Quality Assurance Engineer Remote - New York, New York

Overview

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 have helped 2.5 million people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles. 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 this role is called the Quality Assurance Champion. This role will require close collaboration with a cross-functional development team to ensure software is developed, tested and documented to meet defined requirements, and that we maintain a strong culture of quality.

We are seeking a candidate with a strong personal drive for quality excellence and the motivation to deliver important medical solutions that can improve the lives of millions of people globally.

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 governance.
• Support continuous improvement to the Quality Management System by identifying areas for improvement and engaging in remediation.
• Collaborate with SaMD feature development teams by providing technical and quality support during 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.

Qualifications

Location

In this role you can work remotely as well as from a variety of US-based offices. A flexible work schedule is required to coordinate with team members in Finland.

What we offer

Equal opportunity and additional information

Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. We will not tolerate discrimination or harassment based on protected characteristics. We conduct our pay practices on a market-based basis, and ranges may vary by location. We provide reasonable accommodation to participate in the interview process for individuals with disabilities.

We also provide information about potential scams. Our jobs are listed on the official OURA Careers page and trusted job boards. We will never ask for personal information like IDs or payment for equipment upfront. Official offers are sent through DocuSign after a verbal offer.

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