Senior Quality Engineer

Guardant Health, Inc.; Redwood City (CA); Hybrid; USD 115,000 - 158,000; Full time

Benefits offered by this job

Hybrid Work Model

Job summary

Guardant Health, Inc. is seeking a Senior Quality Engineer to support IVD product development in FDA/ISO-regulated environments. The role provides guidance on Design Controls, Risk Management, stability testing, and validation activities while ensuring compliance with GMP, ISO13485, and CLIA/CAP requirements.

The position emphasizes cross-functional collaboration, documentation excellence, and continuous process improvements within a hybrid work model in the Redwood City area.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or a related scientific discipline.
• 5+ years of quality experience in FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred).
• Experience in molecular biology products or molecular diagnostic products.
• Knowledge of applying statistical methods analysis for testing, process control, and design of experiments.
• Hands-on experience with risk management, process validation, and change control.
• Strong collaborator with demonstrated track record.
• Ability to balance multiple projects in a fast-paced environment.
• Excellent problem-solving and analytical skills.
• Effective communication and interpersonal skills.
• Knowledge of GMP, ISO13485, 21CFR820, CLIA and CAP requirements.
• ASQ CQE certification preferred.
• AI & Digital Fluency demonstrable in line with policy.

Responsibilities

• Point of contact for quality activities related to Guardant Health IVD development and operations.
• Lead supplier management program and related activities.
• Provide guidance on stability testing, sample plan definition, and validation study development.
• Guide qualifications/validations for equipment, facilities, labs, and processes.
• Ensure documentation is completed prior to product transfers and launches.
• Lead cross-functional teams for new products, process improvements, and troubleshooting.
• Oversee risk management and change control activities.
• Support document control, training, CAPAs, nonconforming events, and quality metrics.
• Identify opportunities for continuous improvement and address them with management.
• Perform and document internal audits and recommend corrective actions; conduct external audits.
• Report test quality and safety concerns to supervisor or Safety Officer.

Skills

Quality Assurance

Risk Management

Design of Experiments

Statistical Methods

Molecular Diagnostics

Process Validation

Change Control

Cross-functional Collaboration

Communication

GMP Knowledge

ISO13485

21 CFR 820

ASQ CQE (preferred)

AI & Digital Fluency

Education

Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or related

Tools

IS0/ISO13485

Job description

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, visitguardanthealth.comand follow the company onLinkedIn,X (Twitter)andFacebook.

The Senior Quality Engineer plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, and CMDR regulations. The Quality Engineer also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation and ISO 13485 as well as CLIA, CAP, and applicable state requirements.

Essential Duties and Responsibilities

Point of contact for all quality activities related to the Guardant Health IVD development and Operations activities which include providing guidance for Design Controls, Risk Management, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.

Primary support for supplier management program and related activities which include supplier collaborations and agreements.

Provides guidance on stability testing, sample plan definition, and validation study development.

Provides guidance to qualifications and/or validations respective to equipment, facility, laboratory, and process.

Ensures required documentation is completed prior to product transfers and product launches.

Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities.

Ability to lead Risk Management and Change Control activities.

Support processes such as document control, training, CAPAs, nonconforming event, and developing Quality metrics.

Identifies opportunities for continuous improvements and work with management and team members to successfully address these opportunities.

Perform and document internal audits, make recommendations for corrective actions, and be able to conduct external audits.

Perform 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

Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or a related scientific discipline 5+ years of quality experience in a FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred).

Experience in molecular biology products or molecular diagnostic products

Knowledge of applying statistical methods analysis for testing, process control, and design of experiments

Hands-on experience with risk management, process validation, and change control

Strong collaborator with demonstrated track record.

Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment.

Excellent problem-solving and analytical skills

Effective communication and inter-personal skills

Knowledge of Good Manufacturing Practices.

Working knowledge of ISO13485, 21CFR820, IVDD, CLIA and CAP requirements

ASQ CQE certification preferred.

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.

Salary and Compensation

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: $114,600 - $157,600

Other US Location(s) Base Pay Range: $97,410 - $133,960

If the role is performed in Colorado, the pay range for this job is: $103,140 - $141,840

Work Environment and Physical Requirements

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.

Accommodation and Background Screening

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 [e-mail]

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).

Equal Opportunity Employer

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.

Company Culture

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.