Senior Software Quality Assurance Engineer

Key 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.

Required Qualifications

• 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.

Technical Skills

• 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.

Preferred Attributes

• 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.

Additional Details

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package for US Employees includes:

• 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
• And more!

Additional details about our benefits can be found at our careers page.

We have a 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.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx.

#LI-Remote

This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

San Francisco Bay Area Roles $112,000 - $140,000 USD This is the anticipated base salary range in the United States. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

Remote: US only roles $96,000 - $120,000 USD Apply for this job *

* indicates a required field