Full-Time Senior Quality Engineer

The Senior Quality Engineer plays a critical role in ensuring quality and compliance of Guardant Health's in vitro diagnostic (IVD) products throughout the product lifecycle, from development to manufacturing and supplier interactions.

Essential Duties and Responsibilities:

1. Develops and applies quality requirements for Guardant Health's reagent manufacturing process and quality control activities, including guidance for Production and Process Controls, Risk Analysis, and process validation decisions.
2. Defines and provides guidance for statistical methodologies, sampling plans, and stability testing requirements.
3. Ensures required documentation is completed prior to product transfers and launches.
4. Leads all risk management and change control activities related to reagents.
5. Provides guidance on process and test method validations, re-validations and participates in related change control activities.
6. Supports internal audits, CAPAs, nonconformance investigations, and supplier quality activities.
7. Supports equipment qualification (IQ, OQ, PQ).
8. Supports review of manufacturing records and material disposition, as required.
9. Supports material-related issues and deviations.
10. Identifies opportunities for continuous improvement and collaborates with cross-functional teams.
11. Uses Statistical Process Control (SPC) to ensure product quality, identify areas for improvement, and reduce variability and defects.
12. Generates metrics as required and reports to management.
13. Performs other related duties and responsibilities as assigned.
14. Reports and documents all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.

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