Software Quality Assurance Engineer

Role overview This is a remote Software Quality Assurance Engineer role supporting a digital health organization that develops software-as-a-medical-device products, including an FDA-authorized virtual reality therapeutic for chronic lower back pain. The position partners with Product and Engineering to maintain quality system processes across pre-market development through post-market release, reporting to the Director of QA/RA.

Responsibilities - Establish and maintain software QA processes and controls aligned with FDA regulations, IEC 62304, and recognized standards. - Serve as the Quality partner across Product, Engineering, and SQE teams, driving consistent understanding of QMS requirements from design through release. - Support design and development lifecycle deliverables, including Design History Files, Medical Device Files, and traceability matrices per FDA 21 CFR 820. - Lead risk management activities, including Risk Management Files and Hazard Analyses under ISO 14971, and own CAPA investigations from root cause to closure. - Manage eQMS tool configuration, document routing, and approvals; explore AI-enabled and Model Context Protocol (MCP) solutions to automate workflows while preserving compliance. - Support internal and external audits (including FDA inspections and Notified Body audits) and collaborate on complaint investigations and corrective actions.

Requirements - Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or a related technical discipline. - 5+ years of software product development experience in healthcare, medical device, or digital health/digital therapeutics; familiarity with Agile methodologies. - Working knowledge of medical device development under FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304. - Demonstrated track record in risk management, CAPA ownership, and internal/external auditing. - Six Sigma Green Belt or Black Belt certification (or equivalent process improvement experience). - Proficiency with Propel or comparable eQMS platforms, JIRA, Confluence, and Google Workspace.

Nice to have - Experience applying AI-powered productivity tooling to QA workflows.

Benefits and work setup - Fully remote work-from-home model with comprehensive medical, dental, and vision coverage, plus 401(k) matching. - Flexible time off, 11+ paid holidays per year, accrued sick time (capped at 72 hours), and up to 12 weeks of paid parental leave for new parents.