1. Accountability and ownership for semi-FG, FG, & Raw Material Review, as well as material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.

2. Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

3. Conduct investigation, bounding, documentation, review and approval of NCs, CAPAs and customer complaints. Escalation of quality issues as appropriate.

4. Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

5. Support IQ, OQ, PQ, TMV or Software Validation

产品质量，控制和处置以及性能标准：

1.负责SFG，FG和原材料审查，以及材料识别，材料隔离，缺陷类型分类，包括在制造中日常应用这些技术。

2.收集数据并执行/进行各种分析/统计分析和解释，作为流程改进和日常支持的一部分。

3.对NC，CAPA和客户投诉进行调查，限制，记录，审查和批准，以及必要情况下的升级质量问题。

4.分析/审查预防和纠正措施的有效性。 根据既定流程审查根本原因调查。

5.支持IQ，OQ，PQ，TMV或软件验证

1. Good communication skills in both Chinese & English

2. Mechanical drawing interpretation

3. Statistical analysis tools

4. GMP background is preferred.

1.良好的中英文沟通能力

2.机械制图阅读能力

3.统计分析工具

4.最好有GMP经验