Clinical Quality Engineer II

Guardant Health • Redwood City, CA

9d • 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level