QA Engineer, Sr.
Role summary
CareDx is seeking a Senior Software Quality Assurance Engineer to enhance the quality of software for laboratory workflows and clinical applications. This role requires extensive experience in biotech, diagnostics, or healthcare IT within regulated environments (HIPAA, CLIA, FDA). The engineer will collaborate with cross-functional teams to develop and execute testing strategies, ensuring software meets high standards of quality, safety, and regulatory adherence. Responsibilities include performing various types of testing, validating algorithms, creating test documentation, and supporting release processes. The position is based in Brisbane, CA.
About The Company
CareDx, Inc. is a pioneering leader in the field of precision medicine, dedicated to advancing healthcare solutions for transplant patients and their caregivers. As a company focused on the discovery, development, and commercialization of high-value, clinically differentiated healthcare products, CareDx offers a comprehensive suite of testing services, digital health solutions, and innovative products that support the entire pre- and post-transplant patient journey. Renowned for its expertise in genomics-based information, CareDx is committed to improving patient outcomes through cutting-edge diagnostics and personalized treatment approaches. With a strong emphasis on regulatory compliance and quality, the company operates in a highly regulated environment, ensuring safety, accuracy, and efficacy of its solutions.
About The Role
We are seeking a highly skilled Senior Software Quality Assurance Engineer to join our dynamic team. In this role, you will be instrumental in maintaining and enhancing the quality of multiple software products that support laboratory workflows and clinical applications. The ideal candidate will have extensive experience in biotech, diagnostics, or healthcare IT environments, with a proven track record of working in regulated settings such as HIPAA, CLIA, and FDA compliance. You will collaborate closely with software engineering, product management, and regulatory teams to develop and execute comprehensive testing strategies, ensuring that our software solutions meet the highest standards of quality, safety, and regulatory adherence. This position offers an exciting opportunity to contribute to life-changing healthcare solutions while working in a fast-paced, innovative environment.
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 biotech, diagnostics, healthcare IT, or regulated industries
- Extensive experience with LIMS, laboratory workflows, or reference lab data systems testing
- Proven success in managing multiple projects in dynamic, process-driven environments
- Strong understanding of SDLC, software validation, and release management processes
- Proficiency in backend testing, SQL query development, and test management tools such as Jira, TestRail, Azure DevOps, or Jama
- Experience validating complex algorithms, mathematical models, and clinically-driven formulas
- Excellent communication, problem-solving, and documentation skills
- Experience working in HIPAA-, CLIA-, or FDA-regulated environments
- Local to the Bay Area and able to commute to Brisbane, CA
Responsibilities
- Perform functional, integration, regression, and end-to-end testing for software supporting laboratory workflows and clinical applications
- Conduct software Verification and Validation activities, ensuring algorithms and models used in clinical settings are correct and compliant
- Review functional and technical specifications for accuracy, completeness, and regulatory compliance; identify potential risks and develop mitigation strategies
- Create detailed test plans, test cases, traceability matrices, and validation reports aligned with QMS, HIPAA, CLIA, and FDA standards
- Collaborate with software engineering, product teams, and regulatory personnel to clarify requirements and ensure comprehensive test coverage
- Manage multiple projects simultaneously, maintaining rigorous quality standards and meeting project deadlines
- Support release planning, participate in quality gate reviews, and provide detailed testing summaries and risk assessments
Benefits
- Competitive base salary and performance-based incentives
- Comprehensive health and welfare benefits, including gym reimbursement programs
- 401(k) retirement savings plan with company match
- Employee Stock Purchase Plan (ESPP)
- Pre-tax commuter benefits
- Paid time off and holiday leave
- 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 and diverse workplace. We do not discriminate based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, or any other protected status under applicable law. We participate in the E-Verify program and are dedicated to providing a work environment where all employees can thrive. By submitting your application, you acknowledge that you have read our Privacy Notice and consent to communications from CareDx.
