中核安科锐-法规与质量部-质量工程师（客户投诉）(J23427)

职位描述

岗位职责

1) To be responsible for complaint management, including COMPLAINT procedure and WI, FRMs maintenance to enable product and services, defined strategies and policies, to meet the required standards and regulatory requirements in harmony with business need.

负责投诉管理，包括投诉相关流程、工作指导及表单的维护，确保产品和服务，及确定的战略和方针符合标准和法规的要求并与公司业务要求保持一致。

2) To be responsible for complaint records compliance.

确保投诉记录的合规性。

3) To be responsible for coordinating complaint handling to achieve complaint KPI.

协调投诉处理，确保达成投诉的KPI.

4) To be responsible for having regular meeting with sister company for complaint handling.

与兄弟公司定期召开投诉处理会议。

5) To be responsible for complaint data analysis, and regular complaint related quality report.

负责投诉数据的分析及投诉有关的质量报告。

6) To proactively identify continual improvement opportunities and direct improvements activities achieving

improved efficiency and securing regulatory compliance in alignment with CAMT priorities and the business needs.

积极识别持续改进的机会，并采取直接改进的行动，以达到改进的效率，保障法规和CAMT优先项目和业务需求保持一致。

7) Reporting important quality problems to quality manager.

向质量经理汇报重要的质量问题。

8) Other QA related affairs assigned by leaders, maybe but not limited NCMR handling, IQC, IPQC, FQC and product release, etc.

领导交办的其他QA有关的工作, 包括但不限于不合格处理，进货检验，过程检验，成品检验及产品放行等。

任职要求

任职资格

1) Bachelor degree or above in Mechanical or electrical.

机械类或电子类专业， 本科或以上学历。

2) Familiar with quality management, at least three-year relative medical device working experience.

熟悉质量管理，至少3年医疗器械相关工作经历。

3) Good skills in English, fluent in listening, speaking and writing.

英语水平良好，听说和写作流利。

4) Training in and experience of ISO9001:2015, ISO13485:2016 preferred.

具有ISO9001:2015， ISO 13485:2016培训者优先。

5) Good command of computer, familiar with MS office.

较好掌握电脑，熟悉MS office.

6) Able to work in a multi-cultural, corporate international environment.

能够在多元文化，国际合作的环境下工作。