Senior Software Quality Assurance Engineer

About this role

<div class="content-intro"><p><span style="font-family: times new roman, times, serif;"><span style="font-size: 16px;"> </span></span></p></div><p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-size: 12pt; font-family: 'times new roman', times, serif;"><strong>**Ideal candidate will be in commutable driving distance to Brisbane, CA**</strong> </span></p> <p><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">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.</span></p> <p><span style="font-size: 12pt; font-family: 'times new roman', times, serif;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Perform functional, integration, regression, and end-to-end testing for software supporting laboratory workflows.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Perform software Verification and Validation including algorithms used in clinical and laboratory applications to ensure correctness and compliance.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Review functional and technical specifications for accuracy, completeness, and regulatory compliance; identify risks and contribute mitigation plans.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Develop detailed test plans, test cases, traceability documentation, and software verification and validation reports in alignment with QMS, HIPAA, CLIA, and FDA requirements.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Collaborate with software engineering, product, CLIA, and regulatory teams to ensure clarity of requirements, completeness of test coverage, and alignment on release goals.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Work across several simultaneous projects in a fast-moving environment while maintaining rigorous quality standards and meeting deadlines.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Support release planning, participate in quality gate reviews, and provide detailed test result summaries and risk assessments.</span></li> </ul> <p><span style="font-size: 12pt; font-family: 'times new roman', times, serif;"><strong>Required Qualifications </strong></span></p> <ul> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Education: Bachelor’s/ Master’s degree in Computer Science or equivalent</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Experience: 5+ years of experience in Software Quality Assurance Engineer roles.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">Biotechnology, diagnostics, healthcare IT, or other regulated industry experience strongly preferred.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times new roman', times, serif;">5+ years of LIMS, laboratory workflows, or reference lab data systems testing.</span></li> <li style="font-size: 12pt; font-family: 'times new roman', times, serif;"><span style="font-size: 12pt; font-family: 'times…