Clinical Quality Engineer II

Company DescriptionGuardant 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. Position Summary:The Clinical Quality Engineer II plays an integral role on the Quality team and supports the company's compliance activities with CLIA, CAP, ISO 15189, NYSDOH, and applicable state requirements. This individual also supports the company’s quality activities that comply with the FDA’s Quality System Regulation and ISO 13485 . The Clinical Quality Engineer II works closely with a variety of departments to support quality activities and identify opportunities for continual improvement.Essential Duties and Responsibilities:Support quality activities as it relates to the clinical laboratory, including activities related to pre-analytical, analytical and post analytical phasesSupport issues arising in the clinical laboratory and work closely with Clinical Operations to determining root cause and potential preventative/corrective actionsAssists with creating good laboratory processes and assists with issue resolution.Assist with verification and validation testing and troubleshooting activities.Maintain quality metrics required for management reviewProvides guidance on Change Control activities.Coordinate proficiency testing programReview and improve standard operating procedures / other QMS documentation as neededEnsures required LDT requirements are completed prior to product transfers and product launchesParticipate in inspection readiness activitiesCoordinate proficiency testing program activitiesRepresent Quality at cross functional meetingsReport and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.Ensure that all policies, procedures, and records are reviewed and approvedExecute special projects as assigned Qualifications:M.S. degree or higher in a relevant field with 0–2 years of related experience or a B.S. degree in Chemistry, Biology, Engineering, or a related scientific discipline with 2+ years of quality experience in the Life Sciences industryExperience in compliance with quality standards in a regulated Molecular laboratory (e.g. CLIA, CAP, NYSDOH, etc.)Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departmentsAbility to constructively challenge concerns and engage in transparent conversationsAbility to work effectively in a team environment and build strong working relationshipsAbility to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environmentAbility to identify, analyze and solve problems with minimal direction and escalate concerns to managementProven attention to detail and accuracyEffective organizational skillsHigh degree of initiative and self-motivationDrive for results and continual improvement – Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvementWork Environment: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.AI & Digital FluencyDemonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.Hybrid Work Model:This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients. The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need. Primary Location: Redwood City, CA Primary Location Base Pay Range: $91,100 - $125,300 Other US Location(s) Base Pay Range: $77,435 - $106,505 If the role is performed in Colorado, the pay range for this job is: $81,990 - $112,770Employee 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 View email address on click.appcast.io 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: SummaryLocation: Redwood City, CAType: Full time