Quality Engineer II, Reagents

Guardant Health•Redwood City, CA

7d•$135,600 - $186,450•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

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.

Benefits

Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time.
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.
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/
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