Guardant Health is a pioneer in non-invasive cancer diagnostics and the first company tocommercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate and precise picture of the individual genomic alterations that cause tumors to grow, change, and develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, and our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development and improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish and new uses of our platform are emerging.
We succeed best by coordinating our creative talents and energies to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team.
The Quality Engineer plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, and CMDR regulations. The Quality Engineer also supports the companys quality system activities that comply with the FDAs Quality System Regulation, ISO 13485 as well as CLIA, CAP, and applicable state requirements.
Primary point of contact for all quality activities related to the Guardant Health IVD product development, which includes providing guidance for Design Controls, Risk Analysis, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations
Provides guidance on reagent manufacturing, process validation, and design transfer
Provides guidance on stability testing, sample plan definition, and verification and validation study development
Provides guidance to cross-functional teams responsible for implementation of new products, process improvements
Provides guidance on verification and validation testing and troubleshooting activities
Provides guidance on Change Control activities
Ensures required design history file documentation is completed prior to product transfers and product launches
Support processes such as document control, training, non-conformance, CAPA, and developing Quality metrics
Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
Perform and document internal audits and make recommendations for corrective actions
Performs other related duties and responsibilities as assigned
Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
B.S. degree in Chemistry, Biology, Engineering or a related scientific discipline
Preferred degrees: Biology, Molecular Biology, Bio Medical Eng., Chemistry, Mechanical Eng.
2+ years of quality experience in a FDA/ISO regulated environment
GCLP or GCP experience is a plus
Experience in molecular biology products or molecular diagnostic products - IVD preferred
Knowledge of reagent manufacturing processes
Knowledge of applying statistical analysis for process control, and design of experiments
Strong team player with demonstrated track record
Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
Excellent problem-solving and analytical skills
Effective communication and inter-personal skills
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.