Yoojung Lee

Experience

1. Qaulity Assurance Assistant Manager

   Nano Ditech Corp

   Apr 2023 — Present

   Quality System Regulationo Establish, implement, and maintain the Quality Management System.Quality Activityo Conduct quality audits to assess compliance with cGMP, ISO 13485, FDA QSR 21 CFR 820, EU IVD regulation and other applicable regulation requirements.o Review standard operating procedures and revise or initiate new procedures and systems as needed. o Ensure that the QMS is communicated with all employees by providing training to ensure continual compliance with cGMP, ISO 13485, FDA QSR 21 CFR 820, EU IVD regulation and other applicable regulation requirements. o Provide management of QA function, including oversight of manufacturing device, inspection, labeling and packaging operations and documentation by performing routine ongoing audits on the shop floor. o Perform review of records, and comments to assure that records are complete and accurate. o Ensuring the monitoring, maintenance, and improvement of the quality of products through complaint investigation, failure investigation, product quality and risk assessment and CAPA activity.o Ensure evaluation of, and reporting on, vendor quality systems.o Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.o Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices.o Oversee product recalls.Communicationo Report evaluation of performance of quality management system and any need for improvement to head of quality department

Education

• Dongguk University

  Bachelor's degree, Medical biotechnology

• Columbia University

  American language program

• Northeastern University

  Master's degree, Regulatory affiars