Manager Quality Assurance (Healthcare AI / Software)

Synagen builds specialized AI agents for healthcare and oncology, designed to support complex clinical decisions and biomedical workflows with actionable, high-precision outputs. We combine modern AI with clinical expertise to create software that integrates into real provider environments and delivers value in practice.

Aufgaben

Synagen builds AI-driven software for oncology that must meet the highest standards of reliability, safety, and regulatory readiness. As Manager Quality Assurance, you will own the end-to-end quality framework for our software products—ensuring that what we ship is robustly tested, well-documented, and compliant with applicable regulatory and quality requirements.

You will sit at the intersection of engineering, product, and regulatory, translating regulatory and quality expectations into concrete QA processes, automated testing pipelines, and operational standards that scale with the company.

What you will do

• 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.