Staff Quality Engineer

Guardant Health•Redwood City, CA

46d•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. Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time. Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected] A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952). 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. All your information will be kept confidential according to EEO guidelines. To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants. Please visit our career page at: http://www.guardanthealth.com/jobs/ If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the #1 Top Workplace in the area.

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.