About the Company
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 offers products, testing services, and digital healthcare solutions along the pre‐ and post‐transplant patient journey, and is the leading provider of genomics‐based information for transplant patients.
Location
Ideal candidate will be within commutable driving distance to Brisbane, CA.
Position Overview
Senior Software Quality Assurance Engineer – support quality activities across multiple software products in a fast‐paced, process‐driven, compliance‐focused environment. This role is ideal for candidates with strong experience in biotechnology or diagnostics who can balance multiple concurrent projects, adapt quickly to changing priorities, and ensure the highest level of software quality.
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 or Master's degree in Computer Science or equivalent.
* 5+ years of experience in Software Quality Assurance Engineer roles.
* Biotechnology, diagnostics, healthcare IT, or other regulated industry experience strongly preferred.
* 5+ years of experience with 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, plus 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.
* Local to Bay Area.
Living Donor Employee Recovery Policy
Allows up to 30 days of paid leave annually to a full‐time employee who makes the self‐less act of donating an organ or bone marrow.
Competitive Total Rewards Package for US Employees
* 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.
* Additional benefits as detailed in CareDx benefits overview.
Salary Information
Anticipated base salary range for the Brisbane, California location: $112,000 – $140,000 USD. The final salary offered will depend on experience, education, and other factors. Remote US only roles: $96,000 – $120,000 USD. San Francisco Bay Area roles: $112,000 – $140,000 USD.
Equal Opportunity
CareDx, Inc. is an Equal Opportunity Employer and participates in the E‐Verify program.
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