Note: The job is a remote job and is open to candidates in USA. 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
Skills
- 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
Benefits
- Competitive base salary and incentive compensation
- Health and welfare benefits, including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow
Company Overview