Senior Quality Engineer

Guardant Health

. Support quality activities related to IVD product development in accordance with FDA, ISO, and CMDR regulations .

Posted 9/24/2026full-timeRedwood City • California • United StatesSenior💰 $114,600 - $157,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance activities for IVD product development, ensuring compliance with FDA, ISO, and CMDR regulations. Proficient in risk management, process validation, and statistical methods analysis to support product quality and continuous improvement.

Highest-signal resume keywords

Quality Experience In FDA/ISO Regulated EnvironmentRisk ManagementProcess ValidationKnowledge Of ISO13485, 21CFR820, IVDD, CLIA, CAPASQ CQE Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Methods AnalysisDesign ControlsRisk ManagementProcess ValidationChange ControlStability TestingSample Plan DefinitionInternal AuditsDocument ControlQuality Metrics

Soft Skills

Problem-SolvingAnalytical SkillsEffective CommunicationInterpersonal SkillsCuriosity

Tools & Technologies

AI-Enabled ToolsQuality Management Systems

Certifications & Qualifications

ASQ CQE Certification

Industry Keywords

IVD Product DevelopmentGood Manufacturing PracticesSupplier ManagementContinuous ImprovementNonconforming Events

About the role

Key responsibilities & impact

Support quality activities related to IVD product development in accordance with FDA, ISO, and CMDR regulations
Serve as point of contact for quality activities related to IVD development and operations
Provide guidance for Design Controls, Risk Management, and product development decisions
Support supplier management, supplier collaborations, and agreements
Provide guidance on stability testing, sample plan definition, and validation study development
Guide equipment, facility, laboratory, and process qualifications and validations
Ensure required documentation is completed before product transfers and launches
Guide cross-functional teams implementing new products, process improvements, and troubleshooting activities
Lead Risk Management and Change Control activities
Support document control, training, CAPAs, nonconforming events, and Quality metrics
Identify and address continuous improvement opportunities with management and team members
Perform and document internal audits, recommend corrective actions, and conduct external audits
Report and document test quality and safety concerns to the Supervisor or Safety Officer
Perform other related duties and responsibilities as assigned

Requirements

What you’ll need

Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or a related scientific discipline
5+ years of quality experience in an FDA/ISO regulated environment
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
Ability to balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline-driven environment
Excellent problem-solving and analytical skills
Effective communication and interpersonal skills
Knowledge of Good Manufacturing Practices
Working knowledge of ISO13485, 21CFR820, IVDD, CLIA, and CAP requirements
ASQ CQE certification preferred
Demonstrated curiosity, sound judgment, and ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements
Background screening including criminal history is required

Benefits

Comp & perks

Hybrid work model for eligible onsite employees, including work-from-home days
Flexible work-life balance
Reasonable accommodations for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs
Equal opportunity employment