QA Specialist
美敦力中国
- 公司规模：500-1000人
- 公司性质：外资（欧美）
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2019-11-14
- 工作地点：上海
- 招聘人数：1人
- 工作经验：3-4年经验
- 学历要求：本科
- 职位类别：质量管理/测试工程师(QA/QC工程师)
职位描述
Position Summary:
- Follow the current procedures of regulatory compliance, assist in screening out potential adverse event from complaint events
- Upload regulatory report into global system and complete related task according to WI
- Reporting FER(foreign event reporting) via CFDA web and complete related task into global system
- Closely work with SBU to ensure FER criteria fully meet new AE regulation
- File related document to meet the requirement of company
- Other assignments that may have
Principal Accountabilities:
- Closely work with customer experience management team and ensure no complaint missing initial identify
- Be responsible for assist in screening out potential AE in a time manner;
- Be responsible for FER reporting in a time manner based on CFDA regulation
- Support the quality system objectives and quality function strategies.
- Support for reducing complaint aging time
- Coordinate and submit related materials when necessary
Experience:
- At least 4 years’ experience related to medical device industry or clinical support/operation
- Being familiar with post market regulations, especially for AE (adverse event ) related.
Education:
- Medicine, pharmacy, pharmaceutical analysis, biomedical science or related major, junior college degree or above
职能类别：质量管理/测试工程师(QA/QC工程师)
公司介绍
About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.
联系方式
- 公司地址：北京