Manager Quality Systems /Senior Quality Engineer
江苏费森尤斯医药用品有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-05-29
- 工作地点:常熟
- 招聘人数:1
- 学历要求:本科
- 语言要求:英语
- 职位月薪:面议
- 职位类别:医疗器械生产/质量管理
职位描述
Responsibilities:
1. Participate in maintaining and improving of the Quality Management System and its certification status according to ISO 9001, ISO 13485, MDD and other local requirements coming from the different regulations of markets or countries.
2. Compliation, evaluation, assessment and reporting to management of information and data of the effectiveness of the Quality Management System of GMO AP
3. Support the GMO plants to establish and maintain fully compliant Quality Management Systems that fulfill their local and target markets requirements
4. Improving and Performing Product Quality Reporting for all AP plants
5. Conduct and/or coordinate corporate audits at the AP plants
6. Investigate internal quality issues. Supporting then Plants to resolve them
7. Establish and keep up to date a Production Quality Reporting (Scrap). Liaise with the production departments.
8. Follow up of the implementation and assessment of the effectiveness of corrective action resulting from internal audits of regulatory and certification bodies and authorities.
9. handle ad-hoc assignments with appropriate instructions from supervisory manager.
Qualifications:
1. Completed scientific (university) education with a minimum professional experience of more than 4-5 years.
2. Advanced knowledge of applicable quality management standards (e.g. GMP EU and China, ISO 9001 and ISO 13485) and medical/medicinal devices regulations.
3. Good and professional relationship to and communication with colleagues, subordinates, superiors and to internal and external customers. Integrating attitude and team player.
4. High engagement on achieving the targets and on the objectives of the position, proactive and solution oriented approach towards problems
Good handling of moderation- and presentation technique e.g. written and oral
5. Ability to prioritize multiple projects and tasks.
6. Experience in project management
7. Advanced English language skills
8. Strong interactions with the other QS responsible persons from the different regions within the Fresenius Medical Care GMO organization
9. Need of excellent skills in analysis, innovation, communication, influencing and negotiation
1. Participate in maintaining and improving of the Quality Management System and its certification status according to ISO 9001, ISO 13485, MDD and other local requirements coming from the different regulations of markets or countries.
2. Compliation, evaluation, assessment and reporting to management of information and data of the effectiveness of the Quality Management System of GMO AP
3. Support the GMO plants to establish and maintain fully compliant Quality Management Systems that fulfill their local and target markets requirements
4. Improving and Performing Product Quality Reporting for all AP plants
5. Conduct and/or coordinate corporate audits at the AP plants
6. Investigate internal quality issues. Supporting then Plants to resolve them
7. Establish and keep up to date a Production Quality Reporting (Scrap). Liaise with the production departments.
8. Follow up of the implementation and assessment of the effectiveness of corrective action resulting from internal audits of regulatory and certification bodies and authorities.
9. handle ad-hoc assignments with appropriate instructions from supervisory manager.
Qualifications:
1. Completed scientific (university) education with a minimum professional experience of more than 4-5 years.
2. Advanced knowledge of applicable quality management standards (e.g. GMP EU and China, ISO 9001 and ISO 13485) and medical/medicinal devices regulations.
3. Good and professional relationship to and communication with colleagues, subordinates, superiors and to internal and external customers. Integrating attitude and team player.
4. High engagement on achieving the targets and on the objectives of the position, proactive and solution oriented approach towards problems
Good handling of moderation- and presentation technique e.g. written and oral
5. Ability to prioritize multiple projects and tasks.
6. Experience in project management
7. Advanced English language skills
8. Strong interactions with the other QS responsible persons from the different regions within the Fresenius Medical Care GMO organization
9. Need of excellent skills in analysis, innovation, communication, influencing and negotiation
公司介绍
费森尤斯集团(德国)是一家全球性的医疗保健服务公司,以优质的医疗产品和可信赖的治疗服务享誉全球,是世界五百强企业之一。费森尤斯集团由位于全球范围内的四个独立的事业部组成,包括费森尤斯医疗用品、费森尤斯卡比、费森尤斯赫里奥斯、费森尤斯奥美德。
江苏费森尤斯医药用品有限公司(以下简称“费森尤斯常熟工厂”)隶属于费森尤斯医疗用品,公司成立于2007年7月,是一家集研发和生产功能于一体的企业。公司主要生产用于血液透析的配套产品。现我公司诚邀勤奋敬业、不断超越自我的专业人才加入费森尤斯大家庭!
费森尤斯常熟工厂能为在职员工提供良好的培训与无限的发展空间,同时您也可以在日常工作中领略到多国文化和谐交融的氛围,提高自己的口语水平并拓宽国际视野。另外,公司还为员工提供免费工作餐及常熟市内/苏州班车、年底绩效奖金、带薪年假及其他欧美独资企业所能享有的待遇
江苏费森尤斯医药用品有限公司(以下简称“费森尤斯常熟工厂”)隶属于费森尤斯医疗用品,公司成立于2007年7月,是一家集研发和生产功能于一体的企业。公司主要生产用于血液透析的配套产品。现我公司诚邀勤奋敬业、不断超越自我的专业人才加入费森尤斯大家庭!
费森尤斯常熟工厂能为在职员工提供良好的培训与无限的发展空间,同时您也可以在日常工作中领略到多国文化和谐交融的氛围,提高自己的口语水平并拓宽国际视野。另外,公司还为员工提供免费工作餐及常熟市内/苏州班车、年底绩效奖金、带薪年假及其他欧美独资企业所能享有的待遇
联系方式
- 公司地址:聚富苑民族产业发展基地聚合五街9号