Staff Quality Engineer

Guardant Health•Palo Alto, CA

1d•Hybrid

About The Position

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, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook .

Requirements

Bachelor’s degree in Chemistry, Biology, Engineering or a related scientific discipline.
8+ years of quality experience in a FDA/ISO regulated environment.
Experience in molecular biology products or molecular diagnostic products.
Working knowledge of ISO 13485, ISO 14971 + A11:2021, 21 CFR 820, IVDD, IVDR, CLIA and CAP requirements.
Knowledge of equipment qualifications including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Knowledge of Design Controls and its application
Knowledge of applying statistical analysis for testing, 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.

Nice To Haves

ASQ CQE certification preferred.

Responsibilities

Provides design controls guidance/support for IVD projects in regard to User Needs and Design Input requirements, Subsystem Requirements /Specifications, Design Verification and Validation, Test Method Validation, Risk Management, Design Transfer, Design Reviews and Product Lifecycle Management.
Lead all product Risk Management activities ensuring compliance with ISO 14971.
Ensures design changes are captured and evaluated following the design change control process.
Provides Regulatory and International Standards guidance/support.
Provides guidance on performance studies including stability testing, sample plan definition, and study development.
Manages and mentor junior quality engineers.
Ensures required documentation is completed prior to product transfers and worldwide product launches.
Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.
Supports processes such as document control, nonconformances, CAPAs, and developing Quality metrics.
Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities.
Performs and document internal audits and make recommendations for corrective actions.
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.