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About the Role
We’re seeking a Software Engineer (QA/RA) to help build and support AI/ML-driven medical software. You’ll automate documentation workflows, ensure compliance with medical device standards, and collaborate with QA, regulatory, and engineering teams to deliver high-quality, life-saving technology.
Key Responsibilities
- Automate QA/RA documentation workflows (Jira, Confluence, GitHub).
- Ensure compliance with IEC 62304, ISO 13485 and related standards.
- Build and maintain CI/CD pipelines (e.g., GitHub Actions).
- Write structured documentation (Markdown, reStructuredText, LaTeX).
- Support software verification, validation, and traceability.
- Collaborate with data science teams on AI/ML compliance.
Requirements
- Bachelor’s or Master’s in Software Engineering, Computer Science, or similar.
- 2+ years in software development in a regulated environment.
- Proficient in Python, Git, and CI/CD pipelines.
- Experience with QA/RA standards and documentation tools.
- Strong written and verbal English skills.
Nice to Have
- Experience with AI/ML software.
- Knowledge of ISO 14971 (risk management).
- Familiarity with cloud platforms (e.g., GCP).
Key Skills
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