Quality Engineer, China
唯美血液技术医疗器材(上海)国际贸易有限公司
- 公司规模:50-150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:2016-10-11
- 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
- 语言要求:普通话 熟练 英语 熟练
- 职位月薪:10000-14999/月
- 职位类别:质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述:
- Partners with Complaint coordinators and Manufacturing facilities to analyze failure, CAPA to respond to customer complaints (PIR).
- Daily quality supervision of 3rd party warehouse in China, performing regular inspections and assessments and implementing necessary corrective actions to ensure that warehouse operations comply with local government requirements and company policies.
- Assist Regional Quality Compliance Manager in establishing, implementing and maintaining the quality management system. Create and maintain company quality documentation, such as quality policies, procedures, SOP, records & etc.
- Actively provide individual contributions in problem solving efforts to improve quality.
- Be a contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards.
- Develop training program to build quality awareness in the company.
- Establish measurable quality objectives for the supply base and assist the manufacturing facilities in identifying key quality metrics for supplier delivery and performance.
- The incumbent may be asked to perform other function-related activities in addition to the above mentioned responsibilities as reasonably required by business needs.
Requirements:
Bachelor's Degree in Quality/Engineering or Life Science discipline
3 years and above In a medical device environment presenting and defending quality compliance programs both domestically and internationally
Good written and oral skills In both Chinese and English
Familiar with ISO9001/ ISO13485/FDA QSR
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- Partners with Complaint coordinators and Manufacturing facilities to analyze failure, CAPA to respond to customer complaints (PIR).
- Daily quality supervision of 3rd party warehouse in China, performing regular inspections and assessments and implementing necessary corrective actions to ensure that warehouse operations comply with local government requirements and company policies.
- Assist Regional Quality Compliance Manager in establishing, implementing and maintaining the quality management system. Create and maintain company quality documentation, such as quality policies, procedures, SOP, records & etc.
- Actively provide individual contributions in problem solving efforts to improve quality.
- Be a contributor in the design review of new or modified products. Challenge design assumptions to assure design intent manufacturability and customer acceptance levels are achieved and in compliance with Haemonetics SOPs and regulatory standards.
- Develop training program to build quality awareness in the company.
- Establish measurable quality objectives for the supply base and assist the manufacturing facilities in identifying key quality metrics for supplier delivery and performance.
- The incumbent may be asked to perform other function-related activities in addition to the above mentioned responsibilities as reasonably required by business needs.
Requirements:
Bachelor's Degree in Quality/Engineering or Life Science discipline
3 years and above In a medical device environment presenting and defending quality compliance programs both domestically and internationally
Good written and oral skills In both Chinese and English
Familiar with ISO9001/ ISO13485/FDA QSR
职能类别: 质量管理/测试工程师(QA/QC工程师)
关键字: 质量 投诉
公司介绍
唯美(上海)管理有限公司是美国血液技术公司(Haemonetics Corporation)在中国境内设立的子公司。我们的产品组合包括器械、信息管理和咨询服务,针对血液供应链的所有环节 - 从血浆和血液采集机构到医院 - 提供血液管理方案。 我们坚信,通过合适的血液管理,我们的产品和服务能更好地帮助客户让不用输血的患者不输血,让需要输血的患者输合适的血。
我们的成功始于 1971 年,从那时起,我们提供的设备和耗材就改变了血浆和血液采集中心以及手术室采集和处理血液的方式。 随着行业需求的变化,我们从专注于血液处理系统的医疗器械公司,成为全球领先的血液管理方案供应商。
我们的成功始于 1971 年,从那时起,我们提供的设备和耗材就改变了血浆和血液采集中心以及手术室采集和处理血液的方式。 随着行业需求的变化,我们从专注于血液处理系统的医疗器械公司,成为全球领先的血液管理方案供应商。
联系方式
- 公司地址:上班地址:上海市长乐路989号世纪商贸广场2501-03 & 2510-11室