Kathleen Perrin

QA Engineer for over 10 years, I specialized in the regulated environments of medical devices and digital health - a sector where quality is not an option but a legal requirement.

I have led QA teams (up to 5 people) at medical software publishers (Class IIa / SaMD) such as Allisone.ai or Tribun Health, building the QA department from scratch each time: testing strategy, automation (Python, Playwright, Pytest), and automation of documentation compliant with IEC 62304 / ISO 13485. This rigor around traceability and auditability naturally extends to other regulated sectors where proving that a test has been conceived, executed, and documented is as important as the result itself.

Beyond testing, I develop internal tools that save time for technical and operational teams: CI/CD pipelines, analysis dashboards (SQL, Metabase, HubSpot, Stripe), API integration scripts, and more recently a local AI agent capable of automating certain tasks of a QA engineer.

What I bring concretely:

- Implementation of QA and automation strategies from scratch

- Management of QA teams (internal/external)

- Regulatory documentation and traceability (IEC 62304, ISO 13485, FDA)

- Development of custom tools (Python, JS/TS) to streamline daily team operations

Finally, with my background in biomedical engineering, I am able to understand both the technical challenges and the business constraints of the health sector.

Available for QA lead, test automation, or regulatory compliance missions - medical or any other regulated sector.