Senior Software Quality Assurance Engineer

About this role

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.

**Ideal candidate will be in commutable driving distance to Brisbane, CA**

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

• Education: Bachelor’s/ Master’s degree in Computer Science or equivalent

• Experience: 5+ years of experience in Software Quality Assurance Engineer roles.

• Biotechnology, diagnostics, healthcare IT, or other regulated industry experience strongly preferred.

• 5+ years of LIMS, laboratory workflows, or reference lab data systems testing.

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