Medical Software Quality Analyst
Benefits:
Health insurance (medical, dental, vision)
Retirement planning (401k)
Paid time off
Education Requirements:
Bachelorβs degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field
Experience Requirements:
Minimum of 3-5 years of experience in software quality assurance or quality engineering
Experience in the medical device or healthcare software industry
Project management experience (leading a team or project)
Experience with software medical device quality system validation practices
Experience in Agile/Scrum environments
Other Requirements:
Proficient in Python and Playwright
Knowledge of FDA, ISO 13485, and IEC 62304
Certification in software testing (e.g., ISTQB) is a plus
Knowledge of HIPAA compliance and data privacy regulations
Experience with medical imaging formats such as DICOM
Responsibilities:
Design, develop, and execute test plans and test cases for medical software
Develop manual and automated testing scenarios for AI model results
Ensure compliance with industry standards and regulatory guidelines (FDA, ISO 13485)
Prepare and maintain detailed test documentation and reports
Identify, document, and track software defects
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