Responsibility:
1. Supplier evaluation and management. Perform supplier quality system audit.　　
负责供应商的评估与管理。进行供应商质量审核。
2. Supplier corrective action report follow up.
供应商纠正措施报告跟踪。
3. Handle NCR and CA/PA and be able to support the organization in NCR and CA/PA handling. NCR and CAPA management, verification and validation of Corrective And Preventive Action （CAPA） taken
处理不合格品/流程和纠正预防措施，并能够协助组织的不合格品（流程），纠正预防措施实施的处理。不符合性报告及纠正/预防措施的管理，验证和确认纠正/预防措施的有效性。
4. Process quality problem handling & process improvement.
生产制程质量问题的处理，并追求制程的改善。
5. Perform data trend analysis and report to QA & RA Manager.
对质量数据进行分析并汇报给QARA经理。
6. Assist the QA&RA Manager in all types of audits, and lead the audit as Audit Coordinators.
协助QA&RA经理各种审核工作，并作为审核协调员引导审核。
7. Assist QA & RA Manager to ensure compliance to the latest version of ISO9001, ISO13485, 21 CFR 820, Chinese GMP and CE standards.
协助QA&RA经理以保证对以下最新版本的标准的符合性：ISO9001, ISO13485, 21 CFR 820, 中国GMP和CE认证标准。

Competency requirement:
1. Bachelor’s Degree
本科学历，专业不限
2.Working experience in Quality
QA从业背景
3. Have at least a basic knowledge in statistical methods
基本的统计学知识。
4. Good English speaking & writing skills
英语口语及书面表达优秀。
5. Certified lead auditor is preferred
主任内审员资格证书（优先考虑）
6. Certified ISO 13485/9001 internal auditor is preferred
ISO 13485/9001内审员资格优先考虑。
7. Independent, resourceful, creative, dynamic, result driven and a good team player
独立，有策略，有创造力，富有激情，能够以结果为导向，又团队精神。
8. Pro-active, with good communication skill, leadership skill, problem solving, and analytical skill
主动，良好的沟通技巧，领导才能，分析、解决问题的能力。