QA Engineer – Medical Software (m/w/d)

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.
• eQMSIntegration: 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.

Your profile

Required Experience

• 5+ years of experience in QA or software testing within the medical software domain.
• Strong knowledge of software testing methodologies, QA lifecycle, and SDLC best practices.
• Experience working witheQMSplatforms and managing document control workflows.
• Familiarity with regulatory and quality frameworks such as ISO 13485, IEC 62304, ISO27001, HIPAA and GDPR.
• Hands-on experience with automated testing tools , scripting, and test management platforms.
• Experience with verification & validation of medical or safety-critical software products.

Qualification & Skills

• Bachelor’s or master's in biomedical engineering, ComputerScienceor a related field.
• Excellent written and verbal communication skills in English.
• Ability to work cross-functionally with engineering, product, and regulatory teams.
• Self-starter who thrives in a fast-paced, high-accountability startup environment.

Good to have

• Experience supporting CE marking and/or FDA submissions.
• Experience in digital pathology or oncology diagnostics.
• Understanding of AI/ML model validation challenges in healthcare settings.

Why us?

• The opportunity to make a real difference for cancer patients.
• Competitive salary, stock options, and extra benefits.
• A beautiful office near Alexanderplatz with an on-site gym, private showers, free drinks and snacks, rooftop bar, co-working space, and a quiet room for meditation or prayer.
• Competing at the global top-tier of cancer research together with the founders, who are renowned researchers in the field of AI for biomarker development from medical imaging.
• An extremely fast-paced and high-growth VC-funded start-up environment with key ownership from day 1.

StratifAI is an innovative Berlin-based precision oncology startup developing the next generation of AI-based cancer biomarkers. The founders have published over 100 articles in top-tier journals and founded StratifAI to translate these novel ideas into patient care.

Our products enable cancer patients to receive the right treatment at the right time - both for existing drugs on the market, and by supporting pharmaceutical companies in developing the drugs of tomorrow.

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