Company Description|Job Description
Guardant Health is a pioneer in non-invasive cancer diagnostics & the first company tocommercialize a comprehensive genomic liquid biopsy. Our proprietary digital sequencing technology is transforming cancer treatment by providing an accurate & precise picture of the individual genomic alterations that cause tumors to grow, change, & develop resistance to treatment. We have combined decades of scientific research, advances in laboratory technology, & our breakthrough innovation in liquid biopsy to create new tests that have already handled tens of thousands of samples. We believe our tests can accelerate new drug development & improve the lives of all patients fighting cancer. Our current products are just the beginning of what we hope to accomplish & new uses of our platform are emerging.
We succeed best by coordinating our creative talents & energies to achieve results far beyond what any single individual could accomplish. We seek very talented people who want to be part of our fantastic team.
The Sr. Quality Engineer plays an integral role in supporting quality activities related to IVD product development in accordance with FDA, ISO, & CMDR regulations. The Quality Engineer also supports the company's quality system activities that comply with the FDA's Quality System Regulation & ISO 13485 as well as CLIA, CAP, & applicable state requirements.
- Primary point of contact for all quality activities related to the Guardant Health IVD development activities which includes providing guidance for Design Controls, Risk Analysis, & decisions on product development activities to ensure continued compliance with internal procedures & applicable regulations
- Provides guidance on stability testing, sample plan definition, & validation study development
- Ensures required documentation is completed prior to product transfers & product launches
- Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, & troubleshooting activities
- Leads Change Control activities
- Provides guidance on software development lifecycleactivitiesand documentation.
- Support processes such as document control, training, CAPAs, & developing Quality metrics
- Identifies opportunities for continual improvement & works with management & team members to successfully address these opportunities
- Perform & document internal audits & make recommendations for corrective actions
- Performs other related duties & responsibilities as assigned
- Report & document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
- B.S. degree in Chemistry, Biology, Engineering or a related scientific discipline
- 7+ years of quality experience in a FDA/ISO regulated environment
- GCLP or GCP experience is a plus
- Prior experience with software development for a medical device a plus
- Experience in in molecular biology products or molecular diagnostic products
- Knowledge of applying statistical analysis for process control, & design of experiments
- Strong team player with demonstrated track record
- Ability to successfully balance & prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Excellent problem-solving & analytical skills
- Effective communication & inter-personal skills
- ASQ CQE certification preferred
All your information will be kept confidential according to EEO guidelines.
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