Quality Engineer II, Reagents at Guardant Health, Inc. — Redwood City, CA

Company Description

Position Summary:

The Quality Engineer II plays a key role in ensuring the quality and compliance of Guardant Health’s in vitro diagnostic (IVD) products throughout the product lifecycle – from development to manufacturing. This role is a quality liaison for reagent development, providing expert guidance on Design Controls, Risk Management, Change Control, and Validation activities. The Quality Engineer II contributes to the continuous improvement of Guardant Health’s Quality Management System (QMS) in alignment with FDA regulations (21 CFR 820), ISO 13485, CLIA, CAP, CMDR, and other applicable standards. Additionally, this role supports continuous improvement initiatives, collaborates with cross-functional teams to ensure the successful launch of new products, and collaborates with ongoing quality of innovative healthcare solutions.

Essential Duties and Responsibilities:

• Develops and applies quality requirements for Guardant Health’s reagent manufacturing process and quality control activities. This includes providing guidance for Production and Process Controls, Risk Analysis, and decisions on process validation activities.
• Provides guidance for statistical methodologies, sampling plans, and stability testing requirements.
• Ensures required documentation is completed prior to product transfers and product launches.
• Leads all risk management and change control activities related to reagents.
• Provides guidance on process and test method validations, re-validations, and participates in related change control activities.
• Support internal audits, CAPAs, nonconformance investigations, and supplier quality activities.
• Supports equipment qualification (IQ, OQ, PQ).
• Supports review of manufacturing records and material dispositions, as required.
• Supports material related issues and deviations.
• Identifies opportunities for continuous improvement and collaborates with cross-functional teams to successfully address these opportunities.
• Generate metrics as required and report to management.
• Performs 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.

Qualifications

• B.S. degree in Engineering, Biology, Chemistry, Molecular Biology or related scientific discipline.
• 3+ years of quality experience in and FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred).
• Manufacturing experience is required. Candidates must have hands-on experience working in a manufacturing environment and demonstrate a strong understanding of Good Manufacturing Practices (GMP), quality systems, and standard operating procedures (SOPs).
• Hands-on experience with risk management, process validation, and change control.
• Working knowledge of ISO 13485/FDA 21 CFR 820, and other related regulatory standards.
• Familiar with statistical methods (e.g., statistical analysis, Statistical Process Control, Design of Experiments).
• Familiarity with design control elements and design transfer.
• Ability to successfully balance and prioritize multiple ongoing projects / tasks in a fast-paced, deadline driven environment.
• Strong analytical and problem-solving skills; attention to detail is essential.
• Proficient verbal and written communication skills; able to communicate effective with cross-functional stakeholders.
• Collaborative and self-motivated mindset with a drive for results and process improvement.

Work Environment:

This is an onsite position. Employees may be required to lift routine office supplies and use office equipment. Most 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.

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: $135,600 - $186,450
Other US Location(s) Base Pay Range: $115,260 - $158,483
If the role is performed in Colorado, the pay range for this job is: $122,040 - $167,805 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.