About you:
The software engineering team at Vital is seeking an experienced and driven Software Quality Lead to take ownership of quality assurance and test infrastructure for our medical device software platform. In this pivotal role, you will ensure our software meets stringent FDA and international regulatory standards, while also leading initiatives that bring automation, scalability, and operational excellence to our software development lifecycle.
This role combines deep technical expertise with a strong understanding of regulatory compliance. You will be responsible for building and managing infrastructure for continuous on-device testing, ensuring end-to-end traceability, and automating the generation of quality documentation artifacts required for regulatory submissions.
What you will do:
Own the creation and maintenance of all software quality documentation artifacts required for FDA and international regulatory submissions, including requirements, specifications, traceability, risk assessments, verification protocols, and test reports.
Define and drive the software testing strategy, covering unit, integration, system, and regression testing for both embedded firmware and connected components.
Build and scale infrastructure for automated, continuous on-device testing to support rapid iteration with high reliability.
Design and implement tools and processes to automate the generation of compliance artifacts (e.g., test evidence, traceability matrices, risk documentation) directly from engineering workflows (e.g., Git, CI/CD, ticketing systems).
Ensure traceability from design inputs to verification outputs in compliance with IEC 62304, ISO 14971, and 21 CFR Part 820.
Collaborate with software, systems, and quality teams to align development activities with regulatory and quality requirements.
Monitor and report on quality KPIs such as test coverage, defect trends, and documentation readiness.
Manage a team of software testers that execute testing plans as well as create testing and compliance infrastructure and tooling
Be a quality advocate within the engineering team, driving a culture of reliability, compliance, and technical excellence.
What you will bring:
5+ years of experience in software engineering and software test infrastructure, or related roles, ideally in a regulated industry (medical devices, automotive, aerospace).
Familiarity with FDA software compliance requirements, including IEC 62304, ISO 14971, and 21 CFR Part 820.
Strong hands-on experience with test automation frameworks, CI/CD pipelines, and system testing.
Experience building tools or systems to automate generation of compliance documentation or traceability.
Solid software engineering background with the ability to participate in design and code reviews.
Strong communicator with the ability to work cross-functionally and influence teams toward quality goals.
Bonus: experience with DevOps workflows, requirements management tools, or quality management systems (QMS).
Why Join Us?
You will play a foundational role in how we deliver safe, high-quality software for a next-generation medical device. This is a unique opportunity to build the tools, processes, and systems that make quality and compliance scalable—without slowing innovation. If you are passionate about raising the bar for software quality in healthcare, we want to hear from you.
About Vital
Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.
Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.
We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.
Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance.
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What We Do
Vital was created to enable proactive, preventative, and accessible healthcare. We're starting with a radically disruptive approach to lab testing. Backed by many years of R&D by world-class scientists and engineers, we are a team of collaborators, re-engineering the nature of care delivery.
