岗位职责要求 |
1. Coordinate corporate ＆ external quality system audit, including ISO13485, FDA QSR820, China GMP and Others like MDSAP, etc, and follow up the corrective actions and preventive actions for non conforming,
2. Lead implementation of internal quality system audit and the follow up corrective and preventive activities.
3. Daily maintain and improve the quality system, assure quality system implementation of each department and Cooperate with Global functions to ensure effective communication and implementation of Global QMS requirements related to local site.
4. Collect and maintain related legal requirement of company products, ensure the legal compliance of company products.
5. Assist relative department for building the quality assurance process/system for the new or change process.
6. Training new comers occasionally about quality system
7. Company KPI data collection, management and reporting
8. Continuously contribute, develop and implement ideas that improve performance.
9. Other tasks assigned by the superior.
Requirement:
1. Above 4 years relevant working experience with good English ability
2. Good knowledge of ISO9001 and ISO13485；
3. Familiar with FDA QSR820 quality system, and 93/42/EEC, MDSAP，TS16949 will be preferred
Education Qualification:
Bachelor or above, mechanical/electronic field preferred
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