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 & identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, & state-of-the-art computer science & data science to enhance the scientific understanding of cancer biology, & to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, & the United Kingdom. GRAIL is a wholly-owned subsidiary of Illumina (NASDAQ:ILMN). For more information, please visit www.grail.com.

As a key member of the Quality team at GRAIL, the Staff Design Control Quality Engineer plays an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, & other IVD regulations. This individual also supports the company's quality system activities that align with the FDA's Quality System Regulations (QSRs), ISO 13485, CLIA/CAP, & applicable state requirements. The successful candidate will work with product development teams to ensure that appropriate design control measures are applied during development & transfer of Grail products. The individual will apply systems” thinking & knowledge of medical device products, molecular diagnostics, applicable industry or regulatory standards, design verification & validation, manufacturing transfer, test method development principles, & risk management to support new & sustaining projects.