1). Broad view of quality strategy. Good at solve quality problems on system. -- 20 years professional experience includes 15 years of Quality management covering overall functions of CQE/PQE, SQE, Quality Director，Sr. registration manager/management representative . -- 5 years operational management of full function departments including production,logistics,quality, purchasing and administration ect.. -- Strategy thinking and practical quality management skills base on the long-term/short-term quality methodology. --Team management of 3 to 64 staffs.2). Professional problem-solving quality skills in manufacturing and suppliers. -- 100+ different supplier system and process audits in 11 years. -- Creatively methods to do 4M1E sequential analysis and applied to solve quality problems in process. -- Apply quality tools to solve problems in design, production and marketing: QC Tools, 8D, FMEA, SPC, APQP, PPAP etc. 3). Ability to set up quality system and procedures from 0 to 1 or improve existing procedures. -- Familiar with Systems or regulations including ISO9001, ISO13485, TS16949, FDA QSR, GMP etc. -- 2022, planning and set up ISO13485 quality system for medical company (active, sterile) . -- 2018，successfully merged sheet metal and machining factories (64 staffs team), and led team to set up ISO9001 quality system. 4). Experienced to handle 2nd and 3rd party audit from customers, government, agencies etc. 5). Literal skills to writing procedures, quality documents in Chinese and English. Ability to translate technological or regulation documents. 6). Engineering know-hows of Manufacturing, assembly and testing: -- Medical devices (anesthesia, respirator, monitor, surgical electrode etc.); -- SMT/PCBA, battery, li-battery recycle, motor, cable harness; -- CNC machining.7). Software efficiency by Excel programming skills and ERP( 10+ years of SAP) skills , 8).Deep master of China local culture, communication skills in multi-national, private company culture. -- Mature character with pressure-resistant ability; -- Active and adaptive;