Software Quality Assurance Engineer
Core
Establish and maintain software quality assurance processes and controls to ensure compliance with FDA regulations and medical device standards for VR therapeutic devices.
Role type
Senior Software Quality Assurance Engineer (Medical Device/QMS)
Builds
FDA-compliant VR medical devices for chronic pain management
Domain
Medical device / Digital therapeutics / Virtual Reality
Deliverable
production ML models | product features | dashboards & analysis
Required skills
QMS strategy, risk management lifecycle, CAPA ownership, internal/external auditing, FDA 21 CFR 820 compliance, ISO 14971 hazard analysis, eQMS administration, traceability matrix management
Preferred skills
Agile methodologies, Six Sigma Green/Black Belt, AI-powered workflow automation, MCP/APIs, JIRA/Confluence proficiency
Technologies
Propel, JIRA, Confluence, Google Workspace, eQMS tools
Responsibilities
Establish QMS processes for FDA/IEC 62304 compliance, lead risk management and CAPA investigations, support design history file maintenance, manage eQMS tool administration, assist in FDA/Notified Body audits, resolve post-market software complaints
Seniority
Senior, hands-on IC with cross-functional leadership