Software Quality Assurance Engineer

AppliedVR

. Establish and maintain software quality assurance processes and controls compliant with FDA regulations, IEC 62304, and established standards .

Posted 9/21/2026full-timeRemote • United StatesMid-LevelSenior💰 $125,000 - $155,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software quality assurance processes compliant with FDA regulations and ISO standards, with a strong focus on risk management and CAPA ownership. Proficient in managing eQMS tools and facilitating cross-functional communication in the medical device industry.

Highest-signal resume keywords

FDA 21 CFR 820 ComplianceRisk Management LifecycleCAPA OwnershipEQMS ManagementAgile Methodologies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software Quality AssuranceRisk ManagementMedical Device DevelopmentProcess ImprovementData Integration

Soft Skills

Attention to DetailSolution-Driven MindsetOrganizational SkillsWritten CommunicationVerbal Communication

Tools & Technologies

Propel eQMSJIRAConfluenceGoogle WorkspaceAI-Powered Workflow Automation

Certifications & Qualifications

Six Sigma Green BeltSix Sigma Black Belt

Industry Keywords

HealthcareMedical DeviceDigital HealthIEC 62304ISO 13485

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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