Main responsibilities

1. Being familiar with ISO13485 quality system. 熟悉13485质量体系。

2. Implementing maintaining a quality management system maintain its effectiveness in accordance with the requirement of the 13485 international standard.根据13485 国际标准要求实施和保持质量管理体系，并确保其有效性。

3. Being familiar with YY 0287 standard SFDA’s GMP requirement fmedical device drug.熟悉YY0287要求以及新版医疗期器械GMP要求。

4. Establishing internal audit management review plan, adopt CA PA to ensure the effectiveness of the quality system. 制定年度内审和管理评审计划，对质量体系进行监督，对不合格项采取纠正预防措施,确保质量体系有效性。.

5. Monitor, analyze the quality data work out the quality reports using the quality tools.熟练运用质量工具进行数据分析。

6. Any other assigned tasks.其他指定的工作

7. Report to the quality department head directly. 汇报给质量经理

Qualifications资格:

1. Pharmaceutics biological science education background, college graduated above. 制药学或者生物学教育背景，大专以上学历

2. Minimum 2 year quality working experiences relating the manufacturing industry. The experiences in medical devices are will be preferred.至少2年医疗器械工厂质量工作经验，

3. ISO9000 ISO13485 internal auditcertificate. 质量体系内审员证

4. Honest, active, aggressive personality.诚实，积极，进取，

5. Very good reading writing skill in English. 良好的英文读写能力

6. Well known SPC, FMEA, 7 basic quality tools. 熟悉SPC,FMEA, QC 7大工具

7. Familiar with Micro Office software 熟悉办公软件

Salary: negotiable