Your mission
As QA Engineer, your mission is to ensure that everything we build at StratifAI meets the highest quality standards and regulatory expectations. You will be deeply embedded in the product development lifecycle, integrating testing, documentation and regulatory processes into our agile workflows. You’ll play a key role in organizing technical documentation, maintaining traceability, and ensuring our software and processes meet the rigorous requirements of the medical device industry - helping us deliver the next generation of AI biomarkers safely and securely to patients around the world.
- Technical Documentation: Compile and maintain technical documentation critical to our regulatory and quality standards.
- eQMS Integration: Organize and manage all documentation and testing artifacts within our electronic Quality Management System (eQMS).
- Compliance Management: Ensure we meet all relevant regulatory requirements from the tech-side, including ISO 13485, IEC 62304, ISO27001, HIPAA and GDPR.
- Quality Assurance in Development: Design and implement end-to-end testing strategies across our software stack, working closely with developers and product teams.
- Process tracking: Track and report software quality metrics and compliance KPIs.
- Process Improvement: Continuously enhance our QA processes to support rapid, high-quality development.