岗位职责：
1.In-charge of in-process & out-going quality control and quality improvement。
负责生产过程中、出厂质量控制和质量改进
2.Coordinate with Project & Validation team for process validation.
协调项目及验证团队进行工艺验证。
3.Maintain and ensure processes are aligned with procedures / work instructions and ISO standard.
维护并确保流程符合程序/工作指示和ISO标准。
4.In-charge of product / process criteria and record update.
负责产品/工艺标准和记录的更新。
5.NCP and CAPA management, verification and validation of corrective and preventive action taken and follow-up to ensure on-time closure.
NCP和CAPA的管理，所采取的纠正和预防措施的验证和确认，并进行跟踪以确保及时关闭。
6.Lead investigation, root cause analysis, resolution and closure of complaint, NCR and CAPA.
领导调查，根本原因分析，解决和关闭投诉，NCR和CAPA。
7.Monitoring and reporting on the monthly Quality Objectives achievement.
监督并报告月度质量目标的达成情况。
8.Internal auditor for conducting internal audit. Support external audit.
负责内部审计的内审员。支持外部审计。
9.Perform data analysis on process quality.对工艺质量进行数据分析。
10.Manage and coordinate QC daily operation.管理和协调QC的日常工作。
11.Manage and coordinate Metrology lab daily operation.
管理和协调计量实验室的日常工作。
12.Finish other task which leader assign in time。
及时完成主管交办的其他工作。
岗位要求：
1.College or above，Background in medical device industry is prefer。
大专及以上学历，医疗器械行业背景优先。
2.Min 2 years’ experience in Quality Management System
至少2年以上质量管理体系工作经验
3.ISO knowledge, such as ISO 9001, ISO 13485.
熟悉ISO知识，如ISO 9001， ISO 13485。
4.Good English level ,especial writing
良好的英语水平，尤其是写作。
5.Skill in computer using, such as Microsoft office .etc.
熟练使用电脑，如微软办公软件等。
6.Knowledge in GMP, Clean room controlling and Medical Device is prefer。
有GMP、洁净室控制和医疗器械知识者优先.