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.
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. This role is ideal for candidates with strong experience in biotech 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
5+ years of experience in Software QA Engineering roles. Biotechnology, diagnostics, healthcare IT, or other regulated industry experience strongly preferred. 5+ years of experience in 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.
Education & Experience Requirement
Bachelor's/ Master's degree in Computer Science or equivalent.
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!
Please refer to our page to view detailed benefits at https://caredx.com/company/careers
In addition, 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.
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