Staff / Senior Supplier Quality Engineer (Medical Device/IVD)
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
The Staff Supplier Quality Engineer will be responsible for the management of suppliers within the Supplier Quality team and is accountable for the evaluation, qualification, monitoring, and approval of new and existing suppliers. This position will also help lead the oversight of supplied materials and services to ensure supplier controls are maintained per international requirements and Quality System Regulations.
You will:
- Provide technical support for activities related to supplier quality system assessments and performance evaluations.
- Negotiate and execute Quality Agreements.
- Lead and Support Supplier Quality improvement projects and initiatives
- Review and coordinate Supplier Change Notifications
- Issue and monitor Supplier Corrective Actions.
- Coordinate and execute supplier audits.
- Train, mentor, and coach team members on supplier quality principles.
- Drive and build collaborative working relationships with cross functional teams and suppliers.
- Supports internal audits and inspections.
- Travel as needed for business.
Your qualifications and background will include:
- Bachelor’s Degree in a scientific field.
- Minimum of 8 years of supplier management and auditing experience in a related industry.
- Knowledge in IVDD/IVDR, ISO 13485, and CAP/CLIA preferred.
- Effective written and oral communication skills; ability to write, type, express or exchange ideas accurately.
- Ability to organize and manage multiple projects or tasks.
- Quality orientation and high attention to detail.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.