Remote Software QA Engineer — Medical Device, FDA/ISO

Emploive; Northern (KY); Hybrid; USD 125,000 - 155,000; Full time

Benefits offered by this job

Health benefits

401k with match

Life insurance

Long-term disability

Employee assistance program

Remote stipend

Car allowance

Job summary

AppliedVR is a fully remote company pioneer­ing immersive therapeutics. We seek a Quality Assurance professional to define and drive QMS strategies across product, engineering, and SQE teams in a FDA-regulated medical device context.

You will lead risk management, CAPA ownership, and audits while supporting design, development, and post-market activities with a strong focus on AI-enabled eQMS tooling and regulatory compliance.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or related technical discipline.
• 5+ years of software product development in healthcare/medical device/digital health space.
• Experience with FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304 preferred.
• Proven risk management, CAPA ownership, and auditing experience.

Responsibilities

• Establish and maintain software quality assurance processes and controls for FDA compliance.
• Partner with Product, Engineering, and SQE to drive QMS adoption across lifecycle.
• Support design/development lifecycle and maintain DHF/DDF, MDF, and traceability per FDA 21 CFR 820.
• Lead risk management lifecycle activities and hazard analyses per ISO 14971.
• Own CAPA investigations from root cause to resolution.
• Drive updates to procedures, forms, and systems to improve efficiency.
• Support eQMS tool implementation, including AI-enabled solutions and MCP.

Skills

QMS strategy

Cross-functional leadership

Regulatory compliance

Risk management

CAPA ownership

AI & MCP familiarity

eQMS tools

Agile methodologies

Communication

Autonomy/remote work

Education

Bachelor's degree in CS/Software/EE or related field

Tools

Propel

JIRA

Confluence

Google Workspace

Job description

AppliedVR is a fully remote company pioneer­ing immersive therapeutics. We seek a Quality Assurance professional to define and drive QMS strategies across product, engineering, and SQE teams in a FDA-regulated medical device context.

You will lead risk management, CAPA ownership, and audits while supporting design, development, and post-market activities with a strong focus on AI-enabled eQMS tooling and regulatory compliance.