QA Engineer, Sr.
Role summary
CareDx, Inc. is seeking a Senior Software Quality Assurance Engineer to ensure the quality and compliance of its precision medicine software solutions. This role involves verifying complex algorithms, supporting regulatory adherence (HIPAA, CLIA, FDA), and collaborating with cross-functional teams. The ideal candidate will have 5+ years of QA experience, preferably in biotech/diagnostics, with strong backend testing, SQL, and test management tool skills. Responsibilities include developing test plans, executing various testing types, and contributing to process improvements within a compliance-driven environment.
About The Company
CareDx, Inc. is a pioneering company in the field of precision medicine, dedicated to improving the lives of transplant patients through innovative healthcare solutions. As a leader in genomics-based diagnostics, CareDx specializes in the discovery, development, and commercialization of high-value healthcare products and services tailored to the transplant community. The company's portfolio includes advanced testing services, digital healthcare platforms, and comprehensive solutions that support both pre- and post-transplant patient management. With a commitment to scientific excellence and regulatory compliance, CareDx strives to deliver clinically differentiated products that enhance patient outcomes and support healthcare providers worldwide.
About The Role
We are seeking a highly experienced Senior Software Quality Assurance Engineer to join our dynamic team. In this role, you will be responsible for ensuring the quality and compliance of multiple software products used in laboratory workflows and clinical applications. You will play a critical role in verifying and validating complex algorithms, supporting regulatory adherence, and collaborating with cross-functional teams to deliver reliable, high-quality software solutions. The ideal candidate will have a strong background in biotech or diagnostics, with the ability to manage multiple projects in a fast-paced environment while maintaining rigorous quality standards. This position offers an excellent opportunity to contribute to life-changing healthcare innovations and work within a collaborative, compliance-driven setting.
Qualifications
- Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field
- Minimum of 5+ years of experience in Software QA Engineering, preferably within biotechnology, diagnostics, healthcare IT, or regulated industries
- Extensive experience testing LIMS, laboratory workflows, or reference lab data systems
- Proven success in multi-project, process-driven environments with strict compliance requirements
- Excellent communication, problem-solving, and documentation skills
- Hands-on experience operating within HIPAA, CLIA, or FDA-regulated environments
- Technical proficiency in SDLC, software validation, and release management
- Strong backend testing skills and SQL query development expertise
- Experience with test management and defect tracking tools such as Jira, TestRail, Azure DevOps, or Jama
- Ability to validate complex algorithms, mathematical models, and clinically-driven formulas for accuracy and reliability
Responsibilities
- Perform functional, integration, regression, and end-to-end testing for laboratory and clinical software supporting workflow processes
- Conduct software Verification and Validation activities, ensuring algorithms and models meet clinical and regulatory standards
- Review functional and technical specifications for accuracy, completeness, and regulatory compliance, identifying potential risks and contributing to mitigation strategies
- Develop detailed test plans, test cases, traceability matrices, and verification and validation reports aligned with quality management systems (QMS), HIPAA, CLIA, and FDA requirements
- Collaborate with software engineering, product management, and regulatory teams to clarify requirements, ensure comprehensive test coverage, and align on release timelines
- Manage multiple projects simultaneously in a fast-moving environment while upholding high quality standards and meeting deadlines
- Support release planning activities, participate in quality gate reviews, and provide detailed test result summaries and risk assessments
- Contribute to continuous improvement of testing processes and automation initiatives to enhance efficiency and accuracy
Benefits
- Competitive base salary with incentive compensation
- Comprehensive health and welfare benefits, including gym reimbursement programs
- 401(k) savings plan with company match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- Paid time off and holidays
- Living Donor Employee Recovery Policy offering up to 30 days of paid leave annually for organ or bone marrow donors
- Opportunities for professional growth and development within a mission-driven organization
Equal Opportunity
CareDx, Inc. is an Equal Opportunity Employer committed to fostering an inclusive environment. We welcome applications from all qualified individuals regardless of race, ethnicity, gender, age, disability, sexual orientation, gender identity, or any other characteristic protected by applicable law. We participate in the E-Verify program and ensure fair hiring practices across all our operations.
