GH

GH

Quality Engineer II, Reagents

Redwood City, CA · Mid

Sponsorship not specified$136k-$186kDetected 6 days ago
StatisticsProduct ManagementPatient CareGMPFDA RegulatoryMolecular BiologyMedical DevicesCommunicationCollaborationProblem Solving

About the role

  • The Quality Engineer II plays a key role in ensuring the quality and compliance of Guardant Health's in vitro diagnostic (IVD) products throughout the product lifecycle - from development to manufacturing.
  • The Quality Engineer II contributes to the continuous improvement of Guardant Health's Quality Management System (QMS) in alignment with FDA regulations (21 CFR 820), ISO 13485, CLIA, CAP, CMDR, and other applicable standards.
  • This includes providing guidance for Production and Process Controls, Risk Analysis, and decisions on process validation activities.

Responsibilities

  • Leads all risk management and change control activities related to reagents.
  • Support internal audits, CAPAs, nonconformance investigations, and supplier quality activities.
  • Supports equipment qualification (IQ, OQ, PQ).
  • Supports material related issues and deviations.
  • Identifies opportunities for continuous improvement and collaborates with cross-functional teams to successfully address these opportunities.
  • Performs other related duties and responsibilities as assigned.
  • Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
  • This role is a quality liaison for reagent development, providing expert guidance on Design Controls, Risk Management, Change Control, and Validation activities.
  • If you need support, please reach out to Peopleteam@guardanthealth.com
  • We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires.

Requirements

  • B.S. degree in Engineering, Biology, Chemistry, Molecular Biology or related scientific discipline.
  • Manufacturing experience is required.
  • Candidates must have hands-on experience working in a manufacturing environment and demonstrate a strong understanding of Good Manufacturing Practices (GMP), quality systems, and standard operating procedures (SOPs).
  • Hands-on experience with risk management, process validation, and change control.
  • Working knowledge of ISO 13485/FDA 21 CFR 820, and other related regulatory standards.
  • Ability to successfully balance and prioritize multiple ongoing projects / tasks in a fast-paced, deadline driven environment.
  • Ensures required documentation is completed prior to product transfers and product launches.
  • Supports review of manufacturing records and material dispositions, as required.
  • Generate metrics as required and report to management.
  • Employee may be required to lift routine office supplies and use office equipment.
  • 3+ years of quality experience in and FDA/ISO regulated environment (IVD, molecular diagnostics, or medical devices preferred).
  • Manufacturing experience is required. Candidates must have hands-on experience working in a manufacturing environment and demonstrate a strong understanding of Good Manufacturing Practices (GMP), quality systems, and standard operating procedures (SOPs).
  • Familiar with statistical methods (e.g., statistical analysis, Statistical Process Control, Design of Experiments).
  • Familiarity with design control elements and design transfer.
  • Strong analytical and problem-solving skills
  • attention to detail is essential.
  • Proficient verbal and written communication skills
  • able to communicate effective with cross-functional stakeholders.
  • Collaborative and self-motivated mindset with a drive for results and process improvement.
  • Work Environment:

Compensation

  • $135,600 - $186,450Other
  • $115,260 - $158,483If the role is performed in

Benefits

  • Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer.
  • This range does not include benefits or, if applicable, bonus, commission, or equity.

Equal opportunity

  • All your information will be kept confidential according to EEO guidelines.
Apply directly at GH →Create a free account for alerts like thisView GH immigration profile

This listing is sourced directly from GH's careers page and normalized into a canonical job model.