Senior Quality Engineer (Medical Device )
强生(上海)医疗器材有限公司
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2017-01-28
- 工作地点:上海-徐汇区
- 招聘人数:若干人
- 职位月薪:10-15万/年
- 职位类别:其他
职位描述
职位描述:
1. Principal Duties and Responsibilities
1.1 Support the manager to maintain and improve Product Lifecycle Management in JJMS as per ISO13485:2003, J&J Quality Policy, and regulatory requirements, focused on below items:
支持治疗经理按照ISO13485:2003, J&J质量方针和法规要求维持和提高JJMS产品生命周期管理的符合性,着重在以下方面:
? Maintain change control procedure for Product Lifecycle Management. Coordinate with corss function team and source companies.
维护产品生命周期管理的变更控制流程, 协调跨职能部门和原厂之间的沟通
? Maintain the IFU and sourcing flow management database. Ensure the system running per the requirement of procedure
维护中文说明书和Sourcing flow的管理数据库,确保数据库按照流程要求运作。
? Review the artwork and specification of label and IFU based on the compliance and quality perspective
按照合规性和质量的要求审阅中文说明书和中文标签的图纸规范。
? Support labeling in warehouse with information flow
从信息流方面支持仓库贴标
? Support NPI and NID process
支持新产品导入流程和新产品定义流程。
? Other responsibilities defined in written procedures.
流程中规定的其它职责。
1.2 Fullfill other tasks assigned.
其他指定的工作任务。
1.3 Comply with EHS & ISO14001.
日常行为符合EHS&ISO14001的要求。
2. Basic Requirement
? Bachelor degree on pharmaceutical, medicine, medical device or related subjects.
药学、医学、医疗器械相关专业本科学历。
? 3 year experience in labeling management, quality compliance or related areas in medical device or pharmaceutical industries.
3年以上的医疗器械或药厂标签管理、质量体系符合性或相关领域的经验。
? Good communication skills and leadership.
良好的沟通和领导能力。
? English fluent in reading, writing, oral and listening.
流畅的英文听说读写能力。
? Familiar with routine operations of computer and software.
熟练操作计算机常用功能。
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1. Principal Duties and Responsibilities
1.1 Support the manager to maintain and improve Product Lifecycle Management in JJMS as per ISO13485:2003, J&J Quality Policy, and regulatory requirements, focused on below items:
支持治疗经理按照ISO13485:2003, J&J质量方针和法规要求维持和提高JJMS产品生命周期管理的符合性,着重在以下方面:
? Maintain change control procedure for Product Lifecycle Management. Coordinate with corss function team and source companies.
维护产品生命周期管理的变更控制流程, 协调跨职能部门和原厂之间的沟通
? Maintain the IFU and sourcing flow management database. Ensure the system running per the requirement of procedure
维护中文说明书和Sourcing flow的管理数据库,确保数据库按照流程要求运作。
? Review the artwork and specification of label and IFU based on the compliance and quality perspective
按照合规性和质量的要求审阅中文说明书和中文标签的图纸规范。
? Support labeling in warehouse with information flow
从信息流方面支持仓库贴标
? Support NPI and NID process
支持新产品导入流程和新产品定义流程。
? Other responsibilities defined in written procedures.
流程中规定的其它职责。
1.2 Fullfill other tasks assigned.
其他指定的工作任务。
1.3 Comply with EHS & ISO14001.
日常行为符合EHS&ISO14001的要求。
2. Basic Requirement
? Bachelor degree on pharmaceutical, medicine, medical device or related subjects.
药学、医学、医疗器械相关专业本科学历。
? 3 year experience in labeling management, quality compliance or related areas in medical device or pharmaceutical industries.
3年以上的医疗器械或药厂标签管理、质量体系符合性或相关领域的经验。
? Good communication skills and leadership.
良好的沟通和领导能力。
? English fluent in reading, writing, oral and listening.
流畅的英文听说读写能力。
? Familiar with routine operations of computer and software.
熟练操作计算机常用功能。
职能类别: 其他
公司介绍
强生(上海)医疗器材有限公司诚聘
联系方式
- 电话:13521551953