The Senior Quality Engineer plays a critical role in ensuring the quality and compliance of Guardant Health’s in vitro diagnostic (IVD) products throughout the product lifecycle – from development to manufacturing and supplier interactions. This role is a primary quality liaison for reagent development, providing expert guidance on Design Controls, Risk Management, Change Control, and Validation activities. The Senior Quality Engineer supports and enhances the Quality Management System (QMS) in accordance with FDA regulations (21 CFR 820), ISO 13485, CLIA, CAP, CMDR, and other applicable standards. Additionally, this role drives continual 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
Define and provide 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 disposition, as required
Support material related issues and deviations
Identifies opportunities for continuous improvement and collaborates with cross-functional teams to successfully address these opportunities
Use Statistical Process Control (SPC) to ensure product quality, to identify areas for improvement, and to reduce variability and defects
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 a related scientific discipline
5+ years of quality experience in an FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred)
Working knowledge of design and development in accordance with ISO 13485/FDA 21 CFR 820, and other applicable regulations
Experience with Design Controls, Risk Management, Process Validation, and Change Control
Experience with design control elements and design transfer
Hands-on experience with statistical methods, sampling plans, Statistical Process Control (SPC), and Design of Experiments (DoE)
Knowledge of Good manufacturing practices
Knowledge of Design for Manufacturing (DFM) leading to more efficient and cost-effective production
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; able to communicate effectively with cross-functional stakeholders
Collaborative and self-motivated mindset with a drive for results and process improvement

Additional Information

Hybrid Work Model: At Guardant Health, we have 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.

For positions based in Redwood City, CA, the base salary range for this full-time position is $112,700 to $155,000. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

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 [email protected]

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.

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Please visit our career page at: http://www.guardanthealth.com/jobs/

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