In accordance with regulatory requirements related to MAH (Marketing Authorization Holder), BLA (Biologics License Application), and other applicable regulations, coordinates, compiles, reviews, and ensures the completeness, accuracy, and timely submission of all project-related quality and regulatory documentation packages.
Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
Evaluate new packaging material and ensure the packaging fitness for use and handling of all packing material documentation which is part of quality system.
Test Hardware Integration: Collaborate with PCB and probe card designers to optimize test hardware for power and signal integrity at high speed (PCIe Gen6, HBM4, Maxphy, 400G+ SerDes). Actively debug hardware-software interface issues on the loadboard and probe card levels.
Test Hardware Integration: Collaborate with PCB and probe card designers to optimize test hardware for power and signal integrity at high speed (PCIe Gen6, HBM4, Maxphy, 400G+ SerDes). Actively debug hardware-software interface issues on the loadboard and probe card levels.
Test Hardware Integration: Collaborate with PCB and probe card designers to optimize test hardware for power and signal integrity at high speed (PCIe Gen6, HBM4, Maxphy, 400G+ SerDes). Actively debug hardware-software interface issues on the loadboard and probe card levels.
Test Hardware Integration: Collaborate with PCB and probe card designers to optimize test hardware for power and signal integrity at high speed (PCIe Gen6, HBM4, Maxphy, 400G+ SerDes). Actively debug hardware-software interface issues on the loadboard and probe card levels.