Main Responsibilities:

• Guide the Software team in the implementation of regulatory standards such as 21 CFR Part 11, GMP Annex 11 & 22-IA

• Contribute to quality compliance efforts in alignment with applicable regulatory requirements

• Define, document, and continuously improve the software testing strategy, including manual, automated, integration, and end-to-end tests

• Collaborate closely with developers to ensure code is testable and meets quality expectations

• Ensure the design control (through GAMP5 Framework) processes defined by the Quality team are properly implemented and followed within the Software team

• In collaboration with the Quality team and end users / beta testers, collect and analyze feedback, report bugs and improvement opportunities to the Software team, and support their resolution

• Write, execute, and maintain functional test plans and test cases, including hands-on testing on the machine in collaboration with the Instrument team

• Participate in specification and code reviews to identify and mitigate quality risks early in the development process

• Define and monitor software quality metrics to support continuous improvement and compliance tracking

Required technical skills:

• Fluent in French, with professional proficiency in English (spoken and written)

• Degree in Computer Science, Software Engineering, or a related field

• Proven experience in software quality assurance within an agile development environment

• Prior experience in the medical or life sciences sector

• Familiarity with regulatory standards, including 21 CFR Part 11 and GMP Annex 11

• Knowledge of bug tracking and issue management tools (e.g., Jira, GitHub Issues)

Nice-to-have skills:

• Solid understanding of CI/CD pipelines (e.g., GitLab CI, GitHub Actions, Jenkins)

• Experience in API testing (REST, GraphQL) and integration testing

• Proficiency with automated testing tools such as Cypress, Playwright, Selenium, or Postman

• Working knowledge of a scripting or programming language

• Familiarity with tools such as SonarQube, Allure Report, or TestRail

• 1st interview with Manon (HR BP)

• Fit interview

• Technical interview

• Final interview with Anna (Head of People) and Jérémie (CEO)