Software Quality Assurance Engineer

AppliedVR develops immersive therapeutic virtual reality medical devices for chronic conditions and is focused on transforming healthcare through innovative technology. The Software Quality Assurance Engineer will provide quality assurance oversight for product safety, effectiveness, and regulatory compliance, while establishing QMS processes, leading risk management and CAPA activities, supporting audits, and improving eQMS workflows.

Responsibilities:

• QMS Strategy: Establish and maintain software quality assurance processes, and controls to ensure compliance with FDA regulations, IEC 62304, and established standards
• Cross-Functional Leadership: Act as the Quality partner across Product, Engineering, and SQE teams to drive consistent understanding, adoption, and adherence to QMS requirements from pre-market development through post-market release
• Design and Development: Support the design and development lifecycle deliverables to ensure compliance to existing procedures, and maintaining the Design History File (DHF/DDF), Medical Device File (MDF), and traceability matrices per FDA 21 CFR 820
• Risk Management: Lead risk management lifecycle activities, including authoring and maintaining Risk Management files and Hazard Analyses in accordance with ISO 14971
• CAPA Leadership: Own CAPA investigations from root cause to timely, effective resolution
• Continuous Improvement: Drive updates to procedures, work instructions, forms, and related systems to optimize business efficiency
• Systems & AI Innovation: Support the implementation and continuous improvement of eQMS tools, including AI-enabled solutions and Model Context Protocol (MCP), to automate routine workflows and enhance data accessibility while maintaining regulatory compliance
• Tool Administration: Manage the setup, maintenance, document routing, and approvals within the eQMS system to support team requests
• Audits & Inspections: Support internal and external audits, including FDA inspections and Notified Body audits, and assist in preparing comprehensive responses to observations
• Post-Market Quality: Collaborate cross-functionally to investigate and resolve complaint-related software issues and drive corrective actions

Requirements:

• • Bachelor's Degree in Computer Science, Software Engineering, Electrical Engineering, or related technical discipline
• • 5+ years of software product development experience within the healthcare, medical device, or digital health/digital therapeutics space; working knowledge of Agile methodologies is preferred
• • Experience with medical device development under FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304 strongly preferred
• • Proven track record in risk management, CAPA ownership, and internal/external auditing processes
• • Proficiency with Propel (or similar eQMS), JIRA, Confluence, and Google Workspace
• • Knowledge of AI-powered productivity workflow automation and familiarity with MCP, APIs, and data integration
• • A quality mindset; strong attention to detail, with a solution-driven mindset and a high degree of accountability
• • Demonstrated ability to work cross-functionally and effectively communicate quality assurance requirements and expectations to non-quality stakeholders in a medical device work environment
• • Excellent organizational and written/verbal  communication skills
• • Ability to work autonomously, remotely, in a dynamic, fast-paced environment
• Anywhere in the US. This role requires approximately 10% travel or less for team meetings, audits, or site visits as needed
• • Six Sigma Green Belt or Black Belt certification (or equivalent process improvement experience) preferred, to support continuous process improvement efforts