• Own and continuously evolve Synagen’s software quality assurance strategy across all products.

• Ensure that software releases meet defined quality, robustness, and regulatory readiness criteria.

• Design, implement, and maintain test strategies across unit, integration, system, and regression testing.

• Drive test automation as a first-class capability (CI/CD-integrated, scalable, reproducible).

• Define and maintain test cases, test plans, and acceptance criteria in close collaboration with product and engineering.

• Introduce and operate QA tools and infrastructure (e.g. test management, automated testing frameworks, CI/CD integrations).

• Establish and maintain QA documentation, including test evidence, traceability, and release documentation.

• Work closely with the Regulatory / Privacy / AI Governance Lead to translate regulatory requirements (incl. EU AI Act) into testable quality controls and ensure audit-ready evidence, traceability and release documentation (aligned with ISO 27001/ISO 13485 where applicable)

• Define and enforce QA-related policies, SOPs, and internal standards.

• Act as the central point of accountability for quality-related risks and improvements.

Qualifikation

• 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).

Good to have

• 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.

Why us?

• Build the quality foundation for AI systems used in real oncology workflows.

• High ownership: define how quality and testing are done across the company.

• Direct influence on product robustness, release safety, and regulatory readiness.

• Close collaboration with senior engineering, product, and regulatory leadership.

• Opportunity to professionalize QA in a fast-moving, high-impact environment.