Senior Quality Engineer – IVD Regulatory Compliance

Guardant Health, Inc.; Palo Alto (CA); Híbrido; USD 115 000 - 158 000; Tempo integral

Resumo da oferta

Guardant Health, Inc. is seeking a Senior Quality Engineer to support IVD product development and operations under FDA/ISO regulatory frameworks.

You will lead risk management, change control, supplier oversight, and documentation to ensure compliance and a robust quality system. The role requires a bachelor degree in a science, 5+ years of regulated quality experience, and strong analytical and collaborative skills.

Qualificações

• Bachelor’s degree in Chemistry, Biology, Engineering, Molecular Biology, or related field.
• 5+ years of quality experience in a FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred).
• Experience with 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.

Responsabilidades

• Point of contact for all quality activities related to Guardant Health IVD development and Operations activities including guidance for Design Controls, Risk Management, and decisions on product development activities.
• Primary support for supplier management program and related activities including 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.
• Performother related duties and responsibilities as assigned.

Conhecimentos

Risk management

Change control

Statistical analysis

Documentation

Cross-functional collaboration

ISO 13485 knowledge

21 CFR 820 knowledge

CAP knowledge

Formação académica

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

ASQ CQE certification

Ferramentas

ISO13485 knowledge

21CFR820 knowledge

IVDD knowledge

CLIA/CAP knowledge

Descrição da oferta de emprego

Guardant Health, Inc. is seeking a Senior Quality Engineer to support IVD product development and operations under FDA/ISO regulatory frameworks.

You will lead risk management, change control, supplier oversight, and documentation to ensure compliance and a robust quality system. The role requires a bachelor degree in a science, 5+ years of regulated quality experience, and strong analytical and collaborative skills.