---
title: 'Quality Assurance Lead at CareDx, Inc.'
canonical: 'https://feeny.ai/job/quality-assurance-lead-caredx-inc-brisbane-v5c4jpcsng2k'
type: 'job'
last_seen: '2026-09-08'
---

# Quality Assurance Lead at CareDx, Inc.

- **Company:** CareDx, Inc.
- **Location:** Brisbane, CA
- **Compensation:** $112k–$140k
- **Posted:** 2026-07-15
- **Last confirmed live:** 2026-09-08
- **Apply:** https://job-boards.greenhouse.io/caredxinc/jobs/4301655009

## Job description

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.

As the Quality Assurance (QA) Lead, you will partner across multiple functions to drive quality excellence, ensure compliance with applicable quality system regulations and software standards, and support the continued growth of CareDx's product portfolio.

This highly collaborative role is responsible for implementing and maintaining quality system processes that support CLIA, FDA, and GCLP regulatory requirements. The QA Lead will work closely with cross-functional teams, field personnel, and colleagues across CareDx sites to promote quality compliance, continuous improvement, and operational excellence.

Success in this role requires strong problem-solving skills, the ability to work independently while thriving in a team-oriented environment, and a passion for partnering across departments to achieve shared goals. The QA Lead may also participate in cross-functional project teams and provide Design Control guidance for Laboratory Developed Test (LDT) services, helping ensure quality is embedded throughout the product lifecycle.

Responsibilities:

- Managing the electronic Quality Management System(EQMS) system to assure compliance to inhouse and/or external specifications and standards such as GMPs and CLIA. Includes basic system administrator responsibilities, creating new hire accounts, assigning training requirements, account terminations, training to users on how to use the EQMS, system maintenance such as periodic upgrades and troubleshooting
- Experience with writing and executing EQMS software validation protocols
- Lead Quality System processes for Corrective/Preventive Actions, Supplier Corrective Actions, Supplier Qualifications, Complaints, Non-conforming Materials and Management reviews
- Manufacturing batch record reviews
- Quality review of procedures, forms, and other materials in collaboration with other departments
- Provide general guidance to personnel on quality requirements
- Support GCLP compliance and audits
- Participate in external and internal audits as needed
- Participate in development projects to support design controls and risk management processes
- Any other duty as assigned by QA department management

Qualifications:

- Bachelor of Science degree in scientific field with at least 5-8 years of related experience in Quality Assurance
- General knowledge and understanding of FDA/QMSR, ISO13485 and CLIA
- Experience in a CLIA-regulated laboratory environment and strong knowledge of Laboratory regulations
- Experience with administrator responsibilities for commercially available document control databases strongly desired
- Experience with FDA, CLIA, CAP, NY State audits and inspections preferred
- Knowledgeable in supplier control and supplier monitoring
- Experience in performing internal and external quality audits
- Experience with PCR or RUO or IVD sequencing assays desirable
- Computer skills competency including Excel, Word and PowerPoint programs required
- Demonstrated ability to present to upper Management

Additional Details:

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package for US Employees includes:

- 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
- And more!
- Please refer to our page to view detailed benefits at [https://caredx.com/company/careers](https://caredx.com/company/careers/)

In addition, we have a 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.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our [U.S. Personnel Privacy Notice](https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.caredx.com%2Fus-personnel-privacy-notice&data=05%7C02%7C%7C7909ec363e2b416b016a08de7886b61c%7C9ec77d4e480144b4b8fea5749eaf06b0%7C1%7C0%7C639080717137822026%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=rz649lSGHm5Ca8UOMhbSARMbRhbyMFHdOgEEBXImKs4%3D&reserved=0)https://nam04.safelinks.protection.outlook.com/?url=http%3A%2F%2Fcaredx.com%2Fus-personnel-privacy-notice%2F&data=05%7C02%7C%7C82daf31a87e44746b2ea08dceef5e348%7C9ec77d4e480144b4b8fea5749eaf06b0%7C1%7C0%7C638647987067924758%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=fvNqQdyyA0YaWb3Y4bxHjbbzsxfJ4EmKAEMFQr39KnU%3D&reserved=0and consent to receive email communication from CareDx. Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our [Privacy Policy](https://caredx.com/privacy-center/#ca-privacy)

The U.S. EEO posters are available [here](http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf).

Note: We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us. This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

San Francisco Bay Area Roles: $112,000—$140,000 USD

## About CareDx, Inc.

## Company Overview
- **One-liner**: CareDx is a precision medicine company providing molecular diagnostics, workflow software, patient support, and pharmacy services for transplant patients and, following the acquisition of Naveris, for specialty oncology.
- **Entity Type**: Public (NASDAQ: CDNA)
- **Headquarters**: Brisbane, California, USA (with a co-headquarters in Stockholm, Sweden)
- **Founded**: 2000
- **Founders**: Not publicly available

## Core Business
- **Primary industry/industries**: Transplant diagnostics, precision medicine, molecular testing, healthcare IT, specialty oncology
- **Target customers**: B2B (transplant centers, clinicians, hospitals) and B2C (transplant patients and caregivers)
- **Mission**: Create life-changing solutions that enable transplant patients to thrive.
- **Vision**: A world where every patient receives the transplant they need to live longer, fuller lives.

## Products & Services
- **AlloSure® / AlloMap® / HeartCare® / KidneyCare® / LiverCare®**: Non-invasive molecular monitoring tests (donor-derived cell-free DNA and gene expression profiling) to detect organ rejection earlier in heart, kidney, and liver transplant recipients. (Type: Diagnostic test)
- **CareDx Transplant Pharmacy**: Full-service pharmacy that fills over 150,000 prescriptions annually, providing immunosuppressant and supportive medications. (Type: Service)
- **CareDx Software Suite (e.g., XynManagement, CareDx Connect)**: Workflow tools used by 70% of US transplant centers to manage patient data, lab results, and care coordination. (Type: SaaS)
- **Naveris (acquired July 2026)**: Extends CareDx’s portfolio into high-growth specialty oncology, focusing on circulating tumor DNA (ctDNA) monitoring. (Type: Diagnostic test / Service)

## Market Standing
- **Valuation/Market Cap**: ~$2.5 billion (as of early July 2026) [investors.caredx.com](https://investors.caredx.com/)
- **Key Metric (Annual Revenue)**: $379.8 million (most recent fiscal year) [linkedin.com](https://www.linkedin.com/company/care-dx-inc)
- **Notable Investors/Partners**: Bristol‑Myers Squibb (Series G lead), Sprout Group (Series D lead); partnerships with over 180 commercial employees supporting transplant centers.
- **Growth Signals**: Completed acquisition of Naveris (July 2026) to enter oncology – a high‑growth adjacent market. Completed sale of its Lab Products business to Eurobio Scientific (June 2026) to sharpen focus on diagnostics and digital health. Over 30 abstracts and 9 oral presentations at the 2026 American Transplant Congress. Performed its one‑millionth rejection‑monitoring test.

## Competitive Advantages
- **Market leadership** in transplant diagnostics, serving the vast majority of US transplant centers.
- **Integrated end‑to‑end platform** – from molecular tests and pharmacy to software and patient support – that creates stickiness and deep integration into clinical workflows.
- **Large, real‑world evidence database** from millions of test results, enabling continuous improvement of algorithms and clinical evidence.
- **High barriers to entry**: regulatory clearance (CMS coverage, FDA clearance for certain tests) and long‑standing relationships with transplant centers.

## Strategic Focus
- **Expansion beyond transplant** into specialty oncology via the Naveris acquisition, leveraging existing commercial and diagnostic infrastructure.
- **Deepening digital health and software capabilities** to further integrate with hospital systems and improve patient outcomes.
- **Maximizing value of the transplant franchise** through innovation in molecular monitoring (e.g., new indications, multi‑organ panels) and pharmacy adherence programs.

## Why Work Here
- **Mission‑driven culture**: Employees directly contribute to helping transplant patients live longer, fuller lives.
- **Values**: Respect One Another, Decide with Data, Take Accountability, Evangelize Your Work – emphasizing transparency, data‑driven decisions, and ownership.
- **Benefits**: Competitive medical/dental/vision plans, 401(k) with employer match, Employee Stock Purchase Plan (ESPP), Health Savings Account (HSA), flexible spending accounts, paid time off, living‑donor recovery policy, on‑site gym (Brisbane office).
- **Work environment**: Collaborative, purpose‑driven, with opportunities for growth across diagnostics, biotech, and digital health. Remote/hybrid policy not publicly specified; likely varies by role.

## Sources
1. [caredx.com](https://caredx.com/) – Company overview and product information
2. [caredx.com/company](https://caredx.com/company/) – Mission, leadership, employee count, values
3. [caredx.com/careers](https://www.caredx.com/careers) – Benefits and culture details
4. [investors.caredx.com](https://investors.caredx.com/) – Market cap, recent acquisitions, SEC filings
5. [linkedin.com](https://www.linkedin.com/company/care-dx-inc) – Revenue, employee count, funding history, stock details

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