Software Quality Assurance Engineer

Job not on LinkedIn

🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $125k - $155k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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AppliedVR

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🏥 Healthcare

🥽 AR/VR

🔬 Science

💰 $36M Series B - AppliedVR on 2021-11

Healthcare • AR/VR • Science

AppliedVR is a healthcare company that develops immersive virtual-reality therapeutics combining immersive technology with evidence-based therapeutic techniques (such as cognitive behavioral methods) to support symptom relief and accelerated recovery. The company emphasizes clinical research and scientific rigor, positions its products as validated immersive healthcare solutions, and markets branded offerings such as AVR Pathway, RelieVRx, and SustainVR. AppliedVR's work focuses on using VR experiences to enhance patient engagement and skill-building in clinical contexts rather than purely consumer entertainment.

📋 Description

• 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

🎯 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 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 • Six Sigma Green Belt or Black Belt certification, or equivalent process improvement experience, preferred • 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 • Strong attention to detail, solution-driven mindset, and high degree of accountability • Ability to work cross-functionally and communicate quality assurance requirements to non-quality stakeholders in a medical device work environment • Excellent organizational and written/verbal communication skills • Ability to work autonomously and remotely in a dynamic, fast-paced environment

🏖️ Benefits

• Medical, dental, and vision healthcare benefits • 401k retirement plan with a 4% employer match • Employer-paid life insurance • Long-term disability benefits • Employee assistance program • Remote work stipend • Flexible Time Off for vacation • 11+ paid holidays per year • Sick time accrued at one hour for every 30 hours worked, capped at 72 hours • Up to 12 weeks of paid parental leave for new parents