Quality Assurance Supervisor/Manager--某美资500强医疗企业全球研发中心

 

Position Description

 

·        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.

 

 

Primary Responsibilities

 

·        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.

 

 

 

Key/Critical Competencies

 

·        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

·        Team Player

·        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