Senior Software QA Tester
Core
Lead test strategy, execution, and quality outcomes for regulated medical imaging software and hardware products, ensuring compliance with validation requirements throughout the software development lifecycle.
Role type
Senior Software QA Tester (Regulated Medical Devices)
Builds
Regulated medical imaging software and hardware products
Domain
Medical Devices / Regulated Software
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulated software testing (CSV, CSA, GAMP5, ISO 62304, ISO 62366, 21 CFR Part 11), Test strategy and planning, Manual and automated test execution, Defect lifecycle management, Validation documentation, Process improvement, Mentoring, SQL/MySQL, API testing, Automation framework management
Preferred skills
Experience with React-based UIs, Agile/Scrum environments
Technologies
Selenium, AccelQ, Postman, JMeter, Jira, SQL, MySQL, React
Responsibilities
Own test strategy and coverage decisions using risk-based approaches; Lead manual and automated test execution including regression and UAT; Manage defect lifecycle and conduct root cause analysis; Own validation documentation and support regulatory audits; Lead process improvement initiatives and mentor junior testers.
Seniority
Senior, hands-on IC with mentorship responsibilities