Quality Assurance Lead

Overview

Care Dx, 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. Care Dx 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.

This is an opportunity for a Quality professional to work in a diverse and complex environment and be involved in new and innovative products. Embrace working with multiple departments in a variety of Quality related functions and responsibilities. The Quality Assurance (QA) Lead is responsible for ensuring compliance to applicable quality system regulations. The QA Lead will collaborate inter- and intra-departmentally to implement and support quality system processes in support of ISO, CLIA/CAP, GMP and GCLP regulations.

This requires effective partnerships with personnel internally, in the field and at other Care Dx sites. Requires ability to problem solve, work independently and to function in a team environment. Additionally, it may require participation in cross functional project teams and provide guidance for LDT and IVD regulated products.

• Perform Internal Audit to ISO, GMP, CLIA requirements
• Audit of Suppliers providing critical materials or services
• Qualification of external laboratories for CLIA/CAP
• Planning and support for external audits
• Follow up on internal and external audit findings with stakeholders
• Supplier qualification and performance monitoring, Supplier Corrective Actions
• Processing quality system records such as Corrective/Preventive Actions, Complaints, Non-conforming Materials as needed
• Quality review of procedures, forms, and other materials in collaboration with other departments
• Provide general guidance to personnel on quality requirements
• Support the Electronic Quality Management System (EQMS) to ensure compliance. Includes basic system administrator responsibilities, training users on how to use the EDMS, system maintenance such as periodic upgrades
• Any other duty as assigned by QA department management
• Support the team in Software Development processes as needed (Review and Approve Design Plan, Requirements and Reports)

• Bachelor of Science degree in scientific field preferred with at least 5 years of related experience in Quality Assurance
• Experience in performing internal and external compliance and quality audits
• Experience in a CLIA-regulated laboratory environment desirable
• Very good understanding of CLIA/CAP and FDA/QMSR and GCLP requirements
• General knowledge and understanding of ISO standards: ISO
  13485, 14971, 62304
• Knowledgeable about MDSAP, IVDD and IVDR regulations a plus
• Ability to Travel – up to 25% of your time
• Experience with FDA, CLIA, CAP, NY State audits and inspections preferred
• Knowledgeable in supplier management
• Experience with PCR and sequencing assays desirable
• Experience with Electronic Document Management Systems a plus
• Computer skills competency including Excel, Word and PowerPoint programs required
• Demonstrated ability to present to Management, interact with suppliers, work independently

San Francisco Bay Area Roles:
The anticipated base salary range for candidates who will work in Brisbane, California is $112,000 to $140,000. 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, 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.

Care Dx is a multi-state employer, and this salary range may not reflect positions that work in other states.

Our competitive Total Rewards package 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. For detailed benefits visit

Additional details:
Every individual at Care Dx 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. Care Dx, Inc. is an Equal Opportunity Employer 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 and consent to receive email communication from Care Dx.

We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.