上海招聘

PURPOSE

Why the position exists? The main function of the position

·         Assist, coordinate and support all aspects of QA activities as required.

WORKING RELATIONSHIPS

Internal contacts:

Marketing Team, Sales Team, Supply Chain Team, RA Team

External contacts:

HA, Suppliers and related associations

KEY ACCOUNTABILITIES

Describe in order of relative importance.  In listing principal accountabilities emphasize, where appropriate.

List 4 – 10 of the major and result the position is to accomplish.

u  Coordination of complaint intake and evaluation, both locally and in cooperation with manufacturing plants for investigations.

u  Responsible for Adverse Event reporting activities per local regulation.

u  Perform the complaint reporting training when required.

u  Draft and update the related quality procedures and perform the quality  training per CFDA medical device GSP regulation.

u  Be the role of the training coordinator to assign the training in system and follow up the completion of the training; perform the onsite process/procedure training when required.

u  Be responsible for the field action or product recall.

u  Work with RA to prepare and release the artwork of Chinese labels for imported products.

u  Support and oversee the warehouse for incoming medical devices (direct sale business) prior to their release to the Chinese market.

u  Identify the current operation process and lead the improvement project.

u  Other tasks assigned by manager.

REQUIREMENTS

Skills, education, experience or other qualifications which would be required for anyone who would fill the job.

u  Education Requirement: University graduate with background in medical devices, medicine science, chemistry or pharmacy etc.

u  Language Skills: English level is at or above CET-6 , skilled in written English.

u  Computer Skills: Familiar with the MS software, knowledge of Excel for the data analysis, power point for the monthly presentation, SAP experiences is preferred

u  Other Special requirement: Strong in skills for communication with different parties, independent problem solving ability etc.

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