Software Quality Engineer

Benefits

Additional Information

About AppliedVR AppliedVR is unleashing the power of Immersive Therapeutics (ITx), a new category of medical devices that harness the unique properties of virtual reality (VR) to treat some of the most debilitating chronic conditions. AppliedVR creates non-pharmacologic, non-invasive VR medical devices for in-home therapeutic use. AppliedVR's flagship product, RelieVRx®, is the first FDA-authorized VR device for chronic lower back pain, earning unique CMS recognition and commercial payer coverage. We believe in the power of people. We honor our differences and elevate each other's voices. As a fully remote/work-from-home company, we may not be under the same roof, but we're connected every step of the way via our: 1) core values-we are empathetic, evidence-based, and entrepreneurial; 2) shared mission-solving pain through immersive therapeutics; and 3) our vision-a virtual-reality pharmacy in every home. Learn more about AppliedVR, headquartered in Los Angeles, at appliedvr.io . Job Description AppliedVR is looking for a mission-driven Software Quality Engineer with a passion for transforming healthcare through innovative technology to support our quality assurance and regulatory compliance efforts. Reporting to the Director of QA/RA and working closely with Product and Engineering stakeholders, the initial focus of the Quality Engineer will be providing critical quality oversight to ensure that our products are safe, effective, and compliant. Roles & Responsibilities (are not limited to the following): 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. V&V and Testing: Support verification, validation, and electrical safety/EMC testing (per IEC 60601) to ensure product and QMS compliance, as needed. Post-Market Quality: Collaborate cross-functionally to investigate and resolve complaint-related software issues and drive corrective actions. Experience & Qualifications Preferred Bachelor's Degree in Electrical Engineering, Computer 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 Proven ability to author Verification/Validation (V&V) plans and reports, with knowledge of medical device electrical safety/EMC compliance testing (IEC 60601) and non-product computer system validation (CSV) 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 Location Anywhere in the US. This role requires approximately 10% travel or less for team meetings, audits, or site visits as ne

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at appliedvr? Share your experience