Software Quality 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
Software Quality Engineer (Medical Device/QMS)
Builds
FDA-compliant VR medical devices for chronic pain management
Domain
Medical device / Digital therapeutics / Virtual Reality
Deliverable
client delivery
Required skills
QMS strategy, risk management lifecycle, CAPA ownership, internal/external auditing, V&V planning, eQMS administration, regulatory compliance (FDA 21 CFR 820, ISO 13485, IEC 62304)
Preferred skills
Agile methodologies, electrical safety/EMC testing knowledge, AI-powered workflow automation, MCP/APIs
Technologies
Propel, JIRA, Confluence, Google Workspace
Responsibilities
Establish and maintain software quality assurance processes and controls; Act as Quality partner across Product, Engineering, and SQE teams; Support design and development lifecycle deliverables; Lead risk management lifecycle activities; Own CAPA investigations from root cause to resolution; Drive updates to procedures and work instructions; Support implementation of eQMS tools and AI-enabled solutions; Manage eQMS system setup and maintenance; Support internal and external audits; Support verification, validation, and electrical safety/EMC testing; Collaborate to investigate and resolve complaint-related software issues
Seniority
Mid-Senior, hands-on IC