Senior Quality Engineer

Job Description

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