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发帖数: 295 | 1 Redwood City, CA
有兴趣的话email简历 hzheng At guardanthealth.com
ABOUT THE ROLE
To enable Guardant Health to lead the disruption of cancer treatments
through non-invasive cancer screening, the Quality Team is seeking a highly
motivated Quality Engineer to implement and maintain of a strong supplier
quality program. At Guardant Health, we leverage the most advanced
technologies and partner with leaders in many different fields to create the
most impactful and meaningful technologies for cancer management.
As a Quality Engineer II, you will work with members within the group as
well as with multiple teams, including supply chain management, process
engineering and clinical operations. You will communicate the Guardant
Health quality expectations to the suppliers and partner effectively with
them to ensure that their quality systems and processes fulfill these
expectations.
ABOUT YOU
You’re able to work in a team environment and independently, with little
supervision, create and lead the supplier quality program. You’re highly
committed and are able to deliver results in a hyper-growth start-up
environment. You’re a self-starter and strong team player with a proven
track record. You are an active listener, have good organization skills and
are detail-orientated. You are creative in delivering innovative, effective
and timely solutions. You have the ability to adapt, move fast and embrace
the multiple responsibilities provided.
You will manage all aspects of supplier quality to ensure continued adequacy
and effectiveness of the Guardant Health supplier quality process. You will
work closely with the supply chain department to assess current suppliers
and help in the selection of best-in-class suppliers. You’ll lead supplier
quality audits, ensuring that Guardant Health continuously receives high
quality product and services. You will develop key supplier quality metrics
to support the supplier quality process. You’ll engage directly with the
suppliers to drive quality and process improvements in order to continuously
improve the quality of product and services received by Guardant Health.
You may also be involved in other aspects of the quality system, such as
investigating internal non-conformances, performing internal audits or
developing quality metrics.
In addition, you bring:
5+ years of supplier quality experience in the Life Sciences Industry, with
prior experience in an FDA regulated environment
Working knowledge of medical device / in vitro diagnostic regulations (e.g.,
FDA 21 CRF 820, ISO 13485, IVDD and other applicable quality and regulatory
standards)
Experience in all aspects of supplier quality, including supplier
assessments/audits, maintaining a supplier evaluation program, supplier
corrective actions and supplier process changes
Experience working in a startup, face-paced environment
Excellent interdisciplinary communication skills required
Bachelors degree in engineering, public health or related field
Certified Auditor preferred
Local candidates are preferred
ABOUT OUR COMPANY
Guardant Health develops breakthrough diagnostic technologies to improve
cancer management. With Guardant360, we offer real-time, biopsy-free tumor
sequencing that tracks tumor genomics in real-time and identifies associated
treatment options. The recent introduction of groundbreaking analytical
tools, including our Tumor Response Map and a mobile-enabled physician
portal, further advance Guardant Health's momentum.
Guardant Health has raised almost $200M from OrbiMed, Sequoia Capital,
Khosla Ventures, Lightspeed Venture Partners, and Formation8, and is led by
a seasoned management team of thought leaders and successful serial
entrepreneurs in next generation sequencing and rare cell diagnostics. They
are advised by an oncologist-led medical steering committee from leading
cancer centers. |
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