Quality System Engineer
3M中国有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:多元化业务集团公司
职位信息
- 发布日期:2012-08-23
- 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
- 职位类别:体系工程师/审核员
职位描述
Job Summary:
Maintain and improve quality systems to keep compliance with ISO13485, regulatory and corporate requirements.
Responsibilities:
? Establish, improve and review quality procedures for regulatory compliance and process improvement ;
? Provide quality awareness trainings to plant new employees;
? Conduct routine audit and checking to ensure quality systems requirements are implemented and the procedures are followed closely;
? Organize QMS internal audits to evaluate the suitability, adequacy and effectiveness of the QMS;
? Monitor and follow up CAPA status, summarize CAPA and reports the trends to the managements;
? Assist in external audits, such as SFDA audit, MOH audit, Home Division audit; Notified Body audit, customer audit. Follow up external audit findings;
? Assist in QMS management reviews;
? Provide supports to cross-functions on quality system implementation;
? Perform any other duties as assigned by the supervisor.
Basic Qualifications:
? Bachelor's degree or above with major in material, chemical, biotechnology or other related subjects;
? 3+ years quality system related working experience in a manufacturing environment;
? Depth knowledge of ISO13485/ISO9001;
? Knowledge in China medical device regulations;
? Initiative, communication skills;
? Fluent English communication skill both in written and oral;
? Good PC skills.
Preferred Qualifications:
? Work experience in multinational company;
? Qualified QMS internal auditor;
? Quality system experience in Medical Device or pharmaceutical company;
? Good knowledge of QSR, MDD or GMP.
Maintain and improve quality systems to keep compliance with ISO13485, regulatory and corporate requirements.
Responsibilities:
? Establish, improve and review quality procedures for regulatory compliance and process improvement ;
? Provide quality awareness trainings to plant new employees;
? Conduct routine audit and checking to ensure quality systems requirements are implemented and the procedures are followed closely;
? Organize QMS internal audits to evaluate the suitability, adequacy and effectiveness of the QMS;
? Monitor and follow up CAPA status, summarize CAPA and reports the trends to the managements;
? Assist in external audits, such as SFDA audit, MOH audit, Home Division audit; Notified Body audit, customer audit. Follow up external audit findings;
? Assist in QMS management reviews;
? Provide supports to cross-functions on quality system implementation;
? Perform any other duties as assigned by the supervisor.
Basic Qualifications:
? Bachelor's degree or above with major in material, chemical, biotechnology or other related subjects;
? 3+ years quality system related working experience in a manufacturing environment;
? Depth knowledge of ISO13485/ISO9001;
? Knowledge in China medical device regulations;
? Initiative, communication skills;
? Fluent English communication skill both in written and oral;
? Good PC skills.
Preferred Qualifications:
? Work experience in multinational company;
? Qualified QMS internal auditor;
? Quality system experience in Medical Device or pharmaceutical company;
? Good knowledge of QSR, MDD or GMP.
公司介绍
3M 中国概况
3M公司创建于1902年,全球总部位于美国明尼苏达州的圣保罗市。作为一家世界领先的多元化科技创新企业,3M的产品和技术早已深深地融入人们的生活。100多年以来,3M开发了六万多种产品,从家庭用品到医疗产品,从运输、建筑到商业、教育和电子、通信等各个领域。
3M中国于1984年11月在中国注册成立,是在深圳经济特区外成立的中国***家外商独资企业。截止目前,3M公司在中国建立了9个生产基地、27个办事处、4个技术中心和1个研发中心,员工近8,000人,为***进入中国的外商独资企业之一, 3M中国在过去的30多年里始终密切把握中国经济的发展脉搏,秉承“扎根中国,服务中国”的本土化发展战略,凭借多元化的技术和解决方案,积极支持中国经济的建设和发展。从基础设施建设到制造业崛起,从中国制造到中国创造,从出口驱动到推动内需,3M将企业的发展战略与中国的发展步伐紧密相连,助力中国市场的快速发展。这也使得3M成为中国本土化最成功的企业之一。
3M中国致力开发适合本地市场和客户需求的创新科技和产品,并专注创新人才的培养。目前,3M中国已拥有近600名本土研发人员,贡献了约千项专利发明,并在 3M全球的研发网络中发挥着极为重要的作用。
3M中国积极履行社会责任,积极参与环境保护,扶贫减灾,推进志愿者行动。3M中国的努力得到了社会的广泛认可,获得了“大中华区最具领导力企业”、“最受赞赏的在华外商投资企业”、“亚洲最受尊敬公司二十强”等诸多荣誉,并多次入选“世界500强在华贡献排行榜”且名列前茅。
3M公司创建于1902年,全球总部位于美国明尼苏达州的圣保罗市。作为一家世界领先的多元化科技创新企业,3M的产品和技术早已深深地融入人们的生活。100多年以来,3M开发了六万多种产品,从家庭用品到医疗产品,从运输、建筑到商业、教育和电子、通信等各个领域。
3M中国于1984年11月在中国注册成立,是在深圳经济特区外成立的中国***家外商独资企业。截止目前,3M公司在中国建立了9个生产基地、27个办事处、4个技术中心和1个研发中心,员工近8,000人,为***进入中国的外商独资企业之一, 3M中国在过去的30多年里始终密切把握中国经济的发展脉搏,秉承“扎根中国,服务中国”的本土化发展战略,凭借多元化的技术和解决方案,积极支持中国经济的建设和发展。从基础设施建设到制造业崛起,从中国制造到中国创造,从出口驱动到推动内需,3M将企业的发展战略与中国的发展步伐紧密相连,助力中国市场的快速发展。这也使得3M成为中国本土化最成功的企业之一。
3M中国致力开发适合本地市场和客户需求的创新科技和产品,并专注创新人才的培养。目前,3M中国已拥有近600名本土研发人员,贡献了约千项专利发明,并在 3M全球的研发网络中发挥着极为重要的作用。
3M中国积极履行社会责任,积极参与环境保护,扶贫减灾,推进志愿者行动。3M中国的努力得到了社会的广泛认可,获得了“大中华区最具领导力企业”、“最受赞赏的在华外商投资企业”、“亚洲最受尊敬公司二十强”等诸多荣誉,并多次入选“世界500强在华贡献排行榜”且名列前茅。
联系方式
- Email:LLJiang2@mmm.com
- 公司地址:广州市天河路228号之一广晟大厦25楼