Senior Quality Engineer

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.