Guardant Health needs to ensure the quality and compliance of its in vitro diagnostic (IVD) products, specifically reagents, throughout their lifecycle. This involves addressing challenges in design, development, manufacturing, and supplier collaboration, while adhering to strict regulatory standards.
Requirements
- Deep knowledge of Design Controls, Risk Management, Validation, and Design Transfer.
- Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR 820, and applicable global regulations.
- Experience in statistical analysis, Design of Experiments (DoE), and sampling plans for reagent processes.
- Working knowledge of GMPs, reagent formulation, and stability testing.
Responsibilities
- Lead Design Quality Engineering efforts for reagent product development, verification/validation and design transfer.
- Define and apply quality requirements for reagent manufacturing processes and quality control activities as it relates to process validations and test method validations.
- Provide guidance on Production and Process Controls, sampling plans, and reagent stability testing requirements.
- Lead Risk Management activities and ensure effective integration into design and process decisions.
- Lead process change assessments related to manufacturing process and reagent qualification changes.
- Support design transfer from development to manufacturing, ensuring readiness and compliance for commercial scale-up.
- Support equipment qualifications (IQ/OQ/PQ) for manufacturing and quality control.
Other
- Minimum 8 years of Quality Engineering experience in FDA/ISO regulated environment (IVD preferred).
- Ability to support multiple projects with cross-functional stakeholders in a fast-paced environment.
- Excellent problem-solving, analytical, and communication skills.
- Promote a culture of quality and compliance through training, mentoring, and cross-functional engagement.
- Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
