Senior Quality Engineer - Remote

Overview

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.

In Short

• Develops and applies quality requirements for reagent manufacturing processes.
• Provides guidance for statistical methodologies and stability testing requirements.
• Leads risk management and change control activities.
• Supports internal audits and supplier quality activities.
• Collaborates with cross-functional teams for product launches.
• Uses Statistical Process Control (SPC) to ensure product quality.
• Generates metrics and reports to management.
• Identifies opportunities for continuous improvement.
• Ensures compliance with FDA regulations and ISO standards.
• Performs related duties as assigned.

Requirements

• B.S. degree in Engineering, Biology, Chemistry, or related discipline.
• 5+ years of quality experience in an FDA/ISO regulated environment.
• Knowledge of design and development in accordance with ISO 13485/FDA 21 CFR 820.
• Experience with Design Controls and Risk Management.
• Hands-on experience with statistical methods and Design of Experiments (DoE).
• Strong analytical and problem-solving skills.
• Proficient verbal and written communication skills.
• Collaborative mindset with a drive for results.
• Ability to manage multiple projects in a fast-paced environment.
• Attention to detail is essential.

Benefits

• Flexible work environment with a hybrid work model.
• Competitive salary range.
• Opportunities for professional development.
• Collaborative team culture.
• Comprehensive benefits package.