Senior Product Quality Assurance Engineer
Core
Ensures digital health products comply with quality, safety, and regulatory standards through design controls, verification, and validation.
Role type
Senior Product Quality Assurance Engineer (Digital Health)
Builds
Digital health applications and software products
Domain
Digital Health / Medical Devices / Software Engineering
Deliverable
production ML models | product features
Required skills
FDA design controls, IEC 62304, risk management, CAPA/NCR management, audit execution, AI tool proficiency (VS Code, GitHub Copilot, ChatGPT), phase gate approach
Preferred skills
SaMD applications, IEC 82304, custom AI agents, JIRA/Confluence, statistical analysis for sample sizes
Technologies
VS Code, GitHub Copilot, ChatGPT, JIRA, Confluence
Responsibilities
Perform specialized work applying digital health principles; manage and contribute to digital health projects; offer guidance on quality matters for design and development; participate in internal and external audits; act as a best practice resource
Seniority
Senior, hands-on IC
