Clinical Quality Engineer II

Guardant Health•Redwood City, CA

7d•$91,100 - $125,300•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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.

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

Benefits

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.
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.