Software Quality Assurance Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and uphold software quality assurance processes and controls that adhere to FDA regulations, IEC 62304, and established benchmarks.

• Serve as the Quality partner across Product, Engineering, and SQE teams from the pre-market development phase to post-market release.

• Assist in design and development lifecycle deliverables and sustain the Design History File, Medical Device File, and traceability matrices in compliance with FDA 21 CFR 820.

• Spearhead risk management lifecycle activities and maintain Risk Management files and Hazard Analyses per ISO 14971.

• Oversee CAPA investigations from root cause analysis to prompt and effective resolution.

• Revise procedures, work instructions, forms, and related systems to enhance business efficiency.

• Aid in the implementation and enhancement of eQMS tools, including AI-driven solutions and Model Context Protocol (MCP).

• Manage the setup, maintenance, document routing, and approvals of eQMS.

• Support internal and external audits, FDA inspections, and Notified Body audits.

• Examine and resolve software issues related to complaints and lead corrective action initiatives.

⛳️ Requirements

• Bachelor’s Degree in Computer Science, Software Engineering, Electrical Engineering, or a related technical field.

• Over 5 years of experience in software product development within the healthcare, medical device, or digital health/digital therapeutics sectors.

• Familiarity with Agile methodologies is preferred.

• Experience in medical device development under FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and IEC 62304 is highly preferred.

• Demonstrated success in risk management, CAPA ownership, and both internal and external auditing processes.

• Six Sigma Green Belt or Black Belt certification, or equivalent experience in process improvement, is preferred.

• Proficiency with Propel or similar eQMS, as well as JIRA, Confluence, and Google Workspace.

• Understanding of AI-powered productivity workflow automation and familiarity with MCP, APIs, and data integration.

• Strong attention to detail, a solution-oriented mindset, and a high level of accountability.

• Capacity to work cross-functionally and convey quality assurance requirements to non-quality stakeholders in a medical device environment.

• Excellent organizational, written, and verbal communication skills.

• Ability to operate autonomously and remotely in a dynamic, fast-paced setting.

🏝️ 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 vacations.

• 11+ paid holidays each 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.