AppliedVR

QA Engineer

• Establish and maintain software quality assurance processes and controls compliant with FDA regulations, IEC 62304, and established standards
• Act as the Quality partner across Product, Engineering, and SQE teams from pre-market development through post-market release
• Support design and development lifecycle deliverables and maintain the Design History File, Medical Device File, and traceability matrices per FDA 21 CFR 820
• Lead risk management lifecycle activities and maintain Risk Management files and Hazard Analyses according to ISO 14971
• Own CAPA investigations from root cause through timely, effective resolution
• Update procedures, work instructions, forms, and related systems to improve business efficiency
• Support implementation and improvement of eQMS tools, including AI-enabled solutions and Model Context Protocol (MCP)
• Manage eQMS setup, maintenance, document routing, and approvals
• Support internal and external audits, FDA inspections, and Notified Body audits
• Investigate and resolve complaint-related software issues and drive corrective actions

Software Quality Assurance Engineer