Senior Quality Engineer

Company Description Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.

For more information, visitguardanthealth.comand follow the company onLinked

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The Senior 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 company’s quality system activities that comply with the FDA’s Quality System Regulation and ISO 13485 as well as CLIA, CAP, and applicable state requirements.

Point of contact for all quality activities related to the Guardant Health IVD development and Operations activities which include providing guidance for Design Controls, Risk Management, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.

Primary support for supplier management program and related activities which include supplier collaborations and agreements.

Provides guidance on stability testing, sample plan definition, and validation study development.

Provides guidance to qualifications and/or validations respective to equipment, facility, laboratory, and process.

Ensures required documentation is completed prior to product transfers and product launches.

Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.

Ability to lead Risk Management and Change Control activities.

Support processes such as document control, training, CAPAs, nonconforming event, and developing Quality metrics.

Identifies opportunities for continuous improvements and work with management and team members to successfully address these opportunities.

Perform and document internal audits, make recommendations for corrective actions, and be able to conduct external audits.

Perform 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.

Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or a related scientific discipline 5+ years of quality experience in a FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred).

Experience in molecular biology products or molecular diagnostic products

Knowledge of applying statistical methods analysis for testing, process control, and design of experiments

Hands-on experience with risk management, process validation, and change control

Strong collaborator 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

Knowledge of Good Manufacturing Practices.

Working knowledge of ISO
13485, 21

CFR
820, IVDD, CLIA and CAP requirements

ASQ CQE certification preferred.

AI & Digital Fluency Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory…