QA Specialist
美敦力中国 查看所有职位ShanghaiUpdate time: August 23,2019
Job Description
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)
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联系方式
上班地址：上海
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