CAPU Search is proud to partner with a fast-growing company revolutionizing AI-powered disease diagnostics with its cloud-based platform. Their flagship product has achieved a 93% accuracy in detecting lung cancer by identifying biomarkers from a simple cheek swab. They aim to make diagnostics more accessible, affordable, and scalable across multiple diseases using patented infrared (IR) technology.

The Role:QA Engineer. Medical Devices / SaMD

Location:Remote (UK-based)

Salary:£50,000 - £60,000 per annum. Potential flexibility for the right candidate.

Benefits:Flexible working hours, Smart Pension, 25 days annual leave + bank holidays

We are looking for a QA Engineer to join an agile team and help ensure their product meets the highest quality and safety standards. In this role, you will collaborate with developers, data scientists, and other stakeholders to ensure compliance with industry regulations while contributing to the continuous improvement of their platform.

Key Responsibilities:

• Develop and maintain test plans for a cloud-based medical software product following IEC 62304.
• Conduct functional, integration, system, and regression testing on the web application and machine learning components.
• Collaborate with developers and data scientists to ensure seamless machine-learning model integration.
• Create traceability matrices that link requirements, tests, and risk mitigations.
• Support the verification and validation strategy in accordance with medical device standards.
• Participate in design reviews, risk management, and hazard analysis activities.
• Identify and track software defects using tools such as Jira or Azure DevOps.
• Contribute to developing standard operating procedures (SOPs) aligned with ISO 13485.

Experience required:

• 3-5 years of experience as a QA Engineer, ideally in the medical device or healthcare software industry.
• Strong knowledge of IEC 62304 and ISO 13485 standards.
• Hands-on experience with testing tools such as Selenium, Cypress, or similar.
• Familiarity with machine learning model validation and cloud environments (e.g., AWS, Azure).
• Basic programming skills in Python or JavaScript for testing automation.
• Experience working with CI/CD pipelines and GDPR compliance.
• Detail-oriented with a proactive approach to problem-solving.

The Hiring Process:

• Screening interview with CAPU Search
• 45-minute Zoom assessment with the CTO
• 1-hour technical interview (Zoom or in person) with CTO/CEO

If you are passionate about advancing healthcare technology and want to make a real difference, we’d love to hear from you!