Sr. QA Engineer jobs in United States
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CareDx, Inc. · 16 hours ago

Sr. QA Engineer

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated healthcare solutions for transplant patients and caregivers. They are seeking a highly skilled Senior Software Quality Assurance Engineer to support quality activities across multiple software products in a fast-paced, compliance-focused environment.

BiotechnologyHealth CareHealth DiagnosticsInformation Technology
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H1B Sponsor Likelynote

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

Qualification

Software QA EngineeringBiotechnology experienceLIMS testingSDLC understandingSQL query developmentTest management toolsRegulatory complianceCommunication skillsProblem-solving skillsDocumentation skills

Required

5+ years of experience in Software QA Engineering roles
Biotechnology, diagnostics, healthcare IT, or other regulated industry experience strongly preferred
5+ of 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
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
Bachelor's/ Master's degree in Computer Science or equivalent

Preferred

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
Local to Bay Area

Benefits

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
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.

Company

CareDx, Inc.

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CareDx, Inc., headquartered in South San Francisco, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.

H1B Sponsorship

CareDx, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (8)
2023 (4)
2022 (22)
2021 (21)
2020 (9)

Funding

Current Stage
Public Company
Total Funding
$574.89M
Key Investors
Bristol-Myers SquibbSprout Group
2021-01-21Post Ipo Equity· $164M
2020-06-09Post Ipo Equity· $117.1M
2018-11-13Post Ipo Equity· $52.8M

Leadership Team

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John Hanna
President and CEO
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Nathan Smith
Chief Financial Officer
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Company data provided by crunchbase