Safety Engineer（美国独资医疗设备行业公司，要求熟悉3C，CSA，UL，TUV）
上海帝博企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：外资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-06-20
- 工作地点：上海
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：医疗器械注册
职位描述
Safety Engineer（美国独资医疗设备行业公司，要求熟悉3C，CSA，UL，TUV）
location：上海浦东
Location： 上海浦东
Job Title: Safety Engineer 安规工程师
Reports To: Quality Manager
Purpose/Objective:
To ensure the company to comply with UL,CCC, CSA, TUV and RoHS regulations and to ensure all the practice and procedure in the plant are able to deliver qualified products to the customers.
Area of Responsibilities:
Quality Management
?Implement the applicable regulations and rules for medical devices and meet their requirements.
?Coordinate with related functional teams for companywide safety regulations compliance action plan.
?Continuously monitor and implement the compliance with safety specification and regulations. Coordinate internally to make sure company all external product audits passed.
?Keep in touched with product ownership company to update all of specifications related to our products.
?Communicate with Safety department from government and get the last request or requirement to ensure the regulation compliance.
?Cooperate with R&D department to develop the safety request / specification according to all safety regulations.
?Monitor and review all ECR/ DCR/FAI to ensure all of change have followed the safety specifications.
?Perform internal product audit by detail checklist accord to specification to ensure to archive the target.
Requirements:
?Bachelor degree majoring in Engineering
?Good professional knowledge in optical industry and mechanical industry
?> 3 years of experience in Medical device manufacturing and familiar with FDA QSR820 & ISO13485 requirements.
?Experience of SFDA regulations are preferred
?Good team work spirit and communication skills
?Good English and MS office skill, familiarity with SAP and Lotus preferred.
location：上海浦东
Location： 上海浦东
Job Title: Safety Engineer 安规工程师
Reports To: Quality Manager
Purpose/Objective:
To ensure the company to comply with UL,CCC, CSA, TUV and RoHS regulations and to ensure all the practice and procedure in the plant are able to deliver qualified products to the customers.
Area of Responsibilities:
Quality Management
?Implement the applicable regulations and rules for medical devices and meet their requirements.
?Coordinate with related functional teams for companywide safety regulations compliance action plan.
?Continuously monitor and implement the compliance with safety specification and regulations. Coordinate internally to make sure company all external product audits passed.
?Keep in touched with product ownership company to update all of specifications related to our products.
?Communicate with Safety department from government and get the last request or requirement to ensure the regulation compliance.
?Cooperate with R&D department to develop the safety request / specification according to all safety regulations.
?Monitor and review all ECR/ DCR/FAI to ensure all of change have followed the safety specifications.
?Perform internal product audit by detail checklist accord to specification to ensure to archive the target.
Requirements:
?Bachelor degree majoring in Engineering
?Good professional knowledge in optical industry and mechanical industry
?> 3 years of experience in Medical device manufacturing and familiar with FDA QSR820 & ISO13485 requirements.
?Experience of SFDA regulations are preferred
?Good team work spirit and communication skills
?Good English and MS office skill, familiarity with SAP and Lotus preferred.
公司介绍
DB Talent is a European based recruitment company. Our Shanghai office opened in the 2001, and we have continually provided excellent professional service to our clients and candidates.
联系方式
- 联系人：resume
- 电话：13701722965