Manager Quality Assurance (Healthcare AI / Software)
On-siteBerlin, State of Berlin, Germany
Job Summary
Own and evolve Synagen's software quality assurance strategy across all oncology products, ensuring releases meet robustness, safety, and regulatory readiness criteria. Design and maintain test strategies spanning unit, integration, system, and regression testing while driving automation as a first-class CI/CD capability. Define test cases, plans, and acceptance criteria in collaboration with product and engineering, operating QA tools and infrastructure for scalable, reproducible testing. Establish documentation, traceability, and release evidence aligned with ISO 13485 and the EU AI Act, acting as the central accountability point for quality risks and improvements. Build the quality foundation for AI systems used in real clinical workflows within a startup environment.
Required Qualifications
- Strong experience in software quality assurance in a professional product environment
- Hands-on experience designing and running automated test frameworks
- Solid understanding of test methodologies (unit, integration, system, regression, acceptance)
- Experience working closely with engineering teams and integrating QA into development workflows
- Familiarity with modern QA tooling (e.g. Playwright, Cypress, Selenium, pytest, Postman, GitHub Actions, GitLab CI)
- Ability to structure, document, and operationalize quality processes in growing organizations
- Familiarity with regulated environments and the need for audit-ready documentation
- Practical understanding of EU AI Act requirements and implications for AI-based software quality, testing, and documentation
- Working knowledge of software-relevant standards and expectations in regulated settings (e.g. ISO 27001 alignment, quality documentation, traceability)
- Ability to translate regulatory or compliance requirements into concrete, testable criteria
- Fluent English (written and spoken)
Desired Qualifications
- Experience in digital health, medical software, or healthcare AI
- Exposure to MDR medical device environments or quality management systems (e.g. ISO 13485)
- Experience setting up QA from scratch or scaling it in a startup or scale-up environment
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