Clinical Quality Engineer II
Quality Assurance
Redwood City, CA, USA
USD 108k-148,500 / year
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, 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 phases
- Support issues arising in the clinical laboratory and work closely with Clinical Operations to determining root cause and potential preventative/corrective actions
- Assists 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 review
- Provides guidance on Change Control activities.
- Coordinate proficiency testing program
- Review and improve standard operating procedures / other QMS documentation as needed
- Ensures required LDT requirements are completed prior to product transfers and product launches
- Participate in inspection readiness activities
- Coordinate proficiency testing program activities
- Represent Quality at cross functional meetings
- Report 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 approved
- Execute 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 industry
- Experience 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 departments
- Ability to constructively challenge concerns and engage in transparent conversations
- Ability to work effectively in a team environment and build strong working relationships
- Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
- Proven attention to detail and accuracy
- Effective organizational skills
- High degree of initiative and self-motivation
- Drive 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 improvement
Work 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 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 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.
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 Peopleteam@guardanthealth.com
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/