Senior IVD Quality Engineer — Hybrid & Impact

Guardant Health, Inc.; Redwood City (CA); Hybrid; USD 115,000 - 158,000; Full time

Benefits offered by this job

Hybrid Work Model

Job summary

Guardant Health, Inc. is seeking a Senior Quality Engineer to support IVD product development in FDA/ISO-regulated environments. The role provides guidance on Design Controls, Risk Management, stability testing, and validation activities while ensuring compliance with GMP, ISO13485, and CLIA/CAP requirements.

The position emphasizes cross-functional collaboration, documentation excellence, and continuous process improvements within a hybrid work model in the Redwood City area.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or a related scientific discipline.
• 5+ years of quality experience in 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 balance multiple projects in a fast-paced environment.
• Excellent problem-solving and analytical skills.
• Effective communication and interpersonal skills.
• Knowledge of GMP, ISO13485, 21CFR820, CLIA and CAP requirements.
• ASQ CQE certification preferred.
• AI & Digital Fluency demonstrable in line with policy.

Responsibilities

• Point of contact for quality activities related to Guardant Health IVD development and operations.
• Lead supplier management program and related activities.
• Provide guidance on stability testing, sample plan definition, and validation study development.
• Guide qualifications/validations for equipment, facilities, labs, and processes.
• Ensure documentation is completed prior to product transfers and launches.
• Lead cross-functional teams for new products, process improvements, and troubleshooting.
• Oversee risk management and change control activities.
• Support document control, training, CAPAs, nonconforming events, and quality metrics.
• Identify opportunities for continuous improvement and address them with management.
• Perform and document internal audits and recommend corrective actions; conduct external audits.
• Report test quality and safety concerns to supervisor or Safety Officer.

Skills

Quality Assurance

Risk Management

Design of Experiments

Statistical Methods

Molecular Diagnostics

Process Validation

Change Control

Cross-functional Collaboration

Communication

GMP Knowledge

ISO13485

21 CFR 820

ASQ CQE (preferred)

AI & Digital Fluency

Education

Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or related

Tools

IS0/ISO13485

Job description

Guardant Health, Inc. is seeking a Senior Quality Engineer to support IVD product development in FDA/ISO-regulated environments. The role provides guidance on Design Controls, Risk Management, stability testing, and validation activities while ensuring compliance with GMP, ISO13485, and CLIA/CAP requirements.

The position emphasizes cross-functional collaboration, documentation excellence, and continuous process improvements within a hybrid work model in the Redwood City area.