Senior Software Quality Assurance Engineer

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx is seeking a highly skilled Senior Software Quality Assurance Engineer to support quality activities across multiple software products in a fast-paced, process-driven, compliance-focused environment.

Responsibilities:

• Perform functional, integration, regression, and end-to-end testing for software supporting laboratory workflows
• Perform software Verification and Validation including algorithms used in clinical and laboratory applications to ensure correctness and compliance
• Review functional and technical specifications for accuracy, completeness, and regulatory compliance; identify risks and contribute mitigation plans
• Develop detailed test plans, test cases, traceability documentation, and software verification and validation reports in alignment with QMS, HIPAA, CLIA, and FDA requirements
• Collaborate with software engineering, product, CLIA, and regulatory teams to ensure clarity of requirements, completeness of test coverage, and alignment on release goals
• Work across several simultaneous projects in a fast-moving environment while maintaining rigorous quality standards and meeting deadlines
• Support release planning, participate in quality gate reviews, and provide detailed test result summaries and risk assessments

Requirements:

• Education: Bachelor's/ Master's degree in Computer Science or equivalent
• Experience: 5+ years of experience in Software Quality Assurance Engineer roles
• Biotechnology, diagnostics, healthcare IT, or other regulated industry experience strongly preferred
• 5+ years of LIMS, laboratory workflows, or reference lab data systems testing
• Demonstrated success in highly dynamic, multi-project, process-driven environments
• Excellent communication and problem-solving skills
• Experience operating in HIPAA-, CLIA-, or FDA-regulated environments
• Strong understanding of SDLC, software validation, and release management
• Proficiency with backend testing and SQL query development
• Experience with test management and defect tracking tools (e.g., Jira, TestRail, Azure DevOps, Jama)
• Ability to validate complex algorithms, mathematical models, and clinically-driven formulas for accuracy and reliability
• Exceptional written and verbal communication, with precise documentation skills
• Ability to quickly learn new technologies, tools, and complex domain concepts
• Familiarity with transplant or reference lab environments
• Hands-on automation experience using automated testing tools
• Familiarity with CI/CD pipelines and version control systems
• Local to Bay Area