QA Lead: Quality Systems & Regulatory Compliance

CareDx, Inc.; Brisbane (CA); On-site; USD 112,000 - 140,000; Full time

Benefits offered by this job

Health and welfare benefits, including

Gym reimbursement program

Living Donor Employee Recovery Policy

Job summary

CareDx, Inc. is seeking a QA Lead in Brisbane, CA to drive quality excellence across functions and ensure compliance with quality system regulations and software standards.

You will support the product portfolio through design controls and risk management, partnering with cross‑functional teams and field personnel. The role requires strong problem‑solving and the ability to work independently within a team, with exposure to CLIA, FDA, and GCLP processes and potential design control guidance for

Qualifications

• Bachelor of Science degree in scientific field is preferred with at least 5-8 years of related experience in Quality Assurance.
• Knowledge of FDA/QMSR and CLIA.
• Experience in a CLIA-regulated laboratory environment and strong knowledge of Laboratory regulations desirable.
• 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.

Responsibilities

• Managing the electronic Quality Management System (EQMS) to ensure compliance with GMP/CLIA and internal specs.
• Lead Quality System processes for CAP/QA actions, supplier actions, supplier qualifications, complaints, and management reviews.
• Manufacturing batch record reviews.
• Quality review of procedures and forms in collaboration with other departments.
• Provide guidance on quality requirements to personnel.
• Support GCLP compliance and audits.
• Participate in audits as needed.
• Contribute to design controls and risk management.

Skills

Quality Assurance

Regulatory Compliance

Audit & CAP

Cross-functional collaboration

Problem solving

Education

Bachelor of Science in a scientific field

Tools

EQMS

Excel

Document Control Systems

Job description

CareDx, Inc. is seeking a QA Lead in Brisbane, CA to drive quality excellence across functions and ensure compliance with quality system regulations and software standards.

You will support the product portfolio through design controls and risk management, partnering with cross‑functional teams and field personnel. The role requires strong problem‑solving and the ability to work independently within a team, with exposure to CLIA, FDA, and GCLP processes and potential design control guidance for