张美英 Email and Phone Number

Be good at the QMS such as EN ISO 13485:2016; ISO9001:2015; FDA21CFR820 & other regulations like MDD 93/42/EEC GMP; and know about sterilization like EO sterilization (ISO11135), irradiation sterilization (ISO11137) etc; know some Electrical Medical Device/Electrical Household Device/REACH/PAH regulations and laws, including EMC EN60601-1-2/Safety requirement EN60601-1;EN60335-1 and so on. 2020.07 ISO13485:2016 Internal audit training, and get the certificate; 2015.09 Production process control training at Artsana Group (Italy); 2014.04 Project management training; and get the certificate; 2014.04 Guidance for CE certification, MDD requirement training; 2013.10 ISO9001:2008 registered audit training; and passed the examination; 2012.09 ISO13485:2003 internal audit training, and get the certificate; Know some quality control tools such as QC methods; 8D report, 3A, FMEA, etc. Be good at communication and team work.Know some Manufacturing Processes related to Toys Products (Electronic, Plastic, and Stuffing Toys); Nursery Products (Humidifier, Baby Feeding Bottles, Feeding Sets, Water Filled Teethers) & Medical Products (Wound care products, Nebulizer / Aerosol, Cannula, Hypodermic Needles, Safety Scalp Vein Set, Syringe, Blood Collection System, Blood Glucose Monitoring System, Digital Thermometer).Know some knowledge about the project management about the design & development control from plan to change, such as input, review, feasibility study, prototype, verification, pilot production, mass production etc.