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Role Overview:
- Define and lead quality strategy for SaMD, AI/ML, and connected devices.
- Partner with Engineering, Product, and AI to ensure speed and compliance.
What You'll Be Doing:
- Own V&V strategy and traceability for medical device software.
- Embed shift-left quality, CI/CD gates, and automation into SDLC.
- Drive risk-based thinking and support audits.
What You Need to Have:
- 7+ years software quality engineering, 5+ leading teams in regulated environments.
- Knowledge of IEC 62304, ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
- Track record scaling test automation and CI/CD quality practices.
Sword Health
Sword Health builds AI-powered healthcare care programs, using AI to heal billions and remove barriers to care. With 700,000+ members, 1,000+ enterprise clients, and $500M+ raised, Sword is a fast-paced, clinical-focused AI lab.