Echo Liu Email & Phone Number

中国 上海市区

- Set up Quality management system including distribution and service.- Plan and deploy training matrix, plan and training programs to ensure all quality related roles are effectively trained for quality processes and regulations.- Plan and deploy internal audit on both QMS and GSP regulations. - Execution field corrective action and NC/ CAPA in company and follow up.- Gap assessment for new regulation impact and lead change control process.- Quality agreement preparation for ILS SH / Distributor/ 3PL/ Technical Service Center.- Quality compliance of Shanghai GSP regulation. Quality control through 3PL warehouse.- Medical device distribution license’s maintain and NMPA inspection.- Chinese labeling and IFU management and compliance with NMPA regulation.

Shanghai

Medical Device sector- Optimize process to keep quality compliance of QMS for all DCs in China.- To own the effectiveness of all NC or CAPA completion from DC perspective. - Change Control, Involve in all projects and process of NDC for continuous improvement.- To lead audit in all DCs which include internal audit & external audit and also involved in supplier audit.- Gap assessment for new regulation impact for DC perspective.- To keep the completeness and exclusiveness also effectiveness of Operation standard. Maintain CLS O-Chart and J&D /Setup Training matrix and training plan/ Process review periodically.Consumer Sector- Management review participation- On site audit Gemba Walk bi-weekly- Follow up findings, communicate between sector leader and CLS Q&C.Pharmaceutical sector- Management review participation- Temperature control_ Lane Mapping project coordinateProject:- Synthes Chinese labeling relocation Project Paticipation- Temperature control Project Support_Lane Mapping (Middle risk temperature control product)- BCP Project Leader (DC business continue plan for medical device sector)

Shanghai

-Post Market Surveillance, Field corrective action and assist on complaint handling-Quality Management System-Quality control through 3PL warehouse and internal central distribution center-Product packaging & labeling issue-Act as internal auditor and external lead auditee

Shanghai

-Post Market Surveillance-Be responsible for establishment, implementation and maintenance of quality management system-Set up process for 3PL warehouse quality management to ensure compliance of labeling activities-Define the disposal criteria for non-conforming products control-Resolve labeling issue and IFU management-Update company medical device distribution license.-Responsible for any routine inspection of the warehouse by CFDA

Shanghai

-Be responsible for establishment, implementation and maintenance of quality management system-Control the change to ensure all the change that have impact to certification scope-Document control and deliver training-Plan Internal audit, audit Schedule, implement Internal Audit-Work as internal auditor and external lead auditee;-Manage CAPA System, track, close and verify the effectiveness