Full-Time Senior Quality Engineer

Senior Quality Engineer plays a critical role in ensuring quality and compliance of Guardant Health's IVD products throughout the product lifecycle, from development to manufacturing. This role is a primary quality liaison for reagent development, providing expert guidance on Design Controls, Risk Management, Change Control, and Validation activities.

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.

Drives continual improvement initiatives and collaborates with cross-functional teams to ensure successful product launches.

Essential Duties and Responsibilities:

• Develops and applies quality requirements for reagent manufacturing and quality control activities.
• Provides guidance for Production and Process Controls, Risk Analysis, and process validation activities.
• Defines and guides statistical methodologies, sampling plans, and stability testing requirements.
• Ensures required documentation is completed before product transfers and 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 change control activities.
• Supports internal audits, CAPAs, nonconformance investigations, and supplier quality activities.
• Supports equipment qualification (IQ, OQ, PQ).
• Supports review of manufacturing records and material disposition.
• Supports material-related issues and deviations.
• Identifies continuous improvement opportunities and collaborates with cross-functional teams.
• Uses SPC to ensure product quality, identify improvement areas, and reduce variability.
• Generates and reports metrics to management.
• Reports test quality/safety concerns to Supervisor or Safety Officer.

Qualifications:

• BS 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 according to ISO 13485/FDA 21 CFR 820.
• 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, SPC, and DoE.
• Knowledge of Good manufacturing practices.
• Knowledge of Design for Manufacturing (DFM).
• Ability to prioritize multiple projects.
• Strong analytical, problem-solving skills, and attention to detail.
• Proficient verbal and written communication skills.
• Collaborative and self-motivated mindset.

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