·Establish the quality management system and SOPs, beresponsible for the implementation of company quality management guidelines;
·Responsible to manage all quality audit aspects ofDistributors, Warehouses located in China, and coordinate activities locallywith other functions and regionally/globally;
·Implement Company business philosophy and operatingprinciples. Organize the GSP management and complete the Quality systemaccording to the quality guideline and targets. Make the Quality system workefficiently;
·Be responsible to the company product complaints process andquality management contact person with HQ.
·Oversee all functionalareas listed in terms of systems development, operating metrics setting andachievement.
·Implement the nationallaws, regulations and administrative rules of the relevant quality management.
·Responsible forestablishment/maintenance of QMS through the whole company, including China manufacturing site and Management/Distributionperspective.
·Organize QualityTraining and conduct quality training as needed
·Audit the Qualitysystem document according to the quality guideline and target, and supervisethe implement.
·Efficiently inspect,analyze and improve the implement of the quality management system.
·Be responsible for theinvestigation of medical device quality incidents or quality complaints. Takethe necessary corrective and preventive measures, when the need to improve theoperation management or quality management.
·Supervise the processand improvement of management.
·Supervise and urge theQuality management work.
·Manage quality issuesin partnership with other functions.
·Responsible forself-inspect before GSP declare. Organize the relevant departments to compilethe summary of self-inspect report and be responsible to finalize the summary.
·Responsible for thecheck and declaration of GSP.
·Responsible for thequality relevant work before the declaration of GSP.
·Responsible for thecoordinate work and quality management of GSP audit.
·Maintenance/Responsiblefor China MFG’s production license
·Maintenance/Responsiblefor distribution license as needed
·Apply and maintain forbusiness license change and other support.
·Leading the renewal ofSOPs, ensure the current relevant process is in line with the worldwide QMSrequirements.
·Fluent English andlanguage(s) for assigned territory
·Experience of qualityassurance leadership experience in assigned territory
·Have an understandingof Technical Products, Radiology and Digital
·Proven ProjectManagement skills
·Ability to provideaccurate advice to all levels within the company
·Knowledge of LotusNotes, Access and good level of IT competence.
·Attention to Detail
·Excellent InterpersonalSkills and strong vitual communication skills(e.g. telephone. Electronic media)
·Leadership in DrivingInternal and external Processes
·Must have Sense ofUrgency, must be able to recognize and set priorities
·Close Teamwork toRegulatory Affairs, Sales and Service across business units, Customer ServiceOriented
·Ability to prioritize for maximum results(multi-task management)
Education and Experience
·University level education with equivalence to that of aUnited States level BS, in a science, engineering or health related field (orother relevant discipline)
·A minimum of 8 years directly relevant experience in amedical device or pharmaceutical company. Duties should have includedresponsibility at least one program area and the exercise of independentjudgment in the performance of assigned duties.
·Experience interacting with China product safety certifyingtest labs and the Health Authorities