GH
Clinical Quality Engineer II
Redwood City, CA · Mid
Sponsorship not specified$91k-$125kDetected 25 days ago
Patient CareClinical Laboratory TechniquesFDA RegulatoryCommunicationCollaborationOrganizational Skills
About the role
- Assists with creating good laboratory processes and assists with issue resolution.
- Assist with verification and validation testing and troubleshooting activities.
- Provides guidance on Change Control activities.
Responsibilities
- Support quality activities as it relates to the clinical laboratory, including activities related to pre-analytical, analytical and post analytical phases
- Support issues arising in the clinical laboratory and work closely with Clinical Operations to determining root cause and potential preventative/corrective actions
- Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
- 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
- Experience in compliance with quality standards in a regulated Molecular laboratory (e.g. CLIA, CAP, NYSDOH, etc.)
- Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
- Ability to constructively challenge concerns and engage in transparent conversations
- Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
- Proven attention to detail and accuracy
- High degree of initiative and self-motivation
- Employee may be required to lift routine office supplies and use office equipment.
- Ability to sit for extended periods of time.
- Maintain quality metrics required for management review
- M.S. degree or higher in a relevant field with 0-2 years of related experience or a B.S. degree in Chemistry, Biology, Engineering, or a related scientific discipline with 2+ years of quality experience in the Life Sciences industry
- Ability to work effectively in a team environment and build strong working relationships
- Effective organizational skills
- Drive for results and continual improvement - Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
Compensation
- $77,435 - $106,505If the role is performed in
- $91,100 - $125,300Other US Location(s) Base
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.
Company info
- This individual also supports the company's quality activities that comply with the FDA's Quality System Regulation and ISO 13485.
- The Clinical Quality Engineer II plays an integral role on the Quality team and supports the company's compliance activities with CLIA, CAP, ISO 15189, NYSDOH, and applicable state requirements.
Equal opportunity
- All your information will be kept confidential according to EEO guidelines.
This listing is sourced directly from GH's careers page and normalized into a canonical job model.