Jesse C.
Program Lead at Neuralink
Based in San Francisco, United States
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Seniority
Manager
Department
Information Technology
Location
San Francisco
Industry
Biotechnology Research
Company size
611
Contact information
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j•••••••@neuralink.com
Phone
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Background
About Jesse C.
Pushing the Envelope, with a Culture of Quality & Regulatory Six Sigma | With a rich 12-year background in Manufacturing Operations and Quality Programs, I specialize in steering Regulatory Compliance, Risk Controls, and GxP. I hold numerous ASQ Certifications and a M.S Regulatory Science from JHU. I believe FDA regulatory frameworks can be bolstered with data-driven tools & innovative approaches. Currently working on Brain-computer interface (BCI) Neurotech products. Regulatory Six Sigma: operational excellence for FDA compliance and burdensome regulatory requirements. Favorite Metric = Right First Time (RFT). Expertise = Leadership, GMP, CAPA, Risk Management, Quality Systems, Regulatory Affairs, HHE, Recalls, FMEA, HACCP, ISO 13485, ISO 14971, Six Sigma, Change Control, Supplier Quality, Contract Manufacturing, Supply Chain, Design Controls. Regulatory Landscape: Proficient across FDA, USDA, FTC, EPA, CPSC. 21 CFR 820, 812, 211, 210, 803, 117, ISO 13485, ISO 14971, ISO 9001, etc.
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