Sr. QMS Specialist
赛默飞世尔(上海)管理有限公司
- 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：2017-11-10
- 工作地点：上海-浦东新区
- 工作经验：无工作经验
- 职位月薪：2-2.5万/月
- 职位类别：体系工程师
职位描述
职位描述：
1. Position Summary: What is the main purpose of this job? Why does it exist? (e.g., to create marketing strategies; to develop, support and grow Compliance awareness etc.) Please summarize in two to three sentences.
？ The position will be responsible to establishing, maintaining and enhancing company’s Quality Management System with China commercial organization, in order to supervise all quality processes to ensure full compliance to regulatory and corporate quality requirements.
2. Principal Accountabilities: What are the key responsibilities of this job? List the what, how and why of each responsibility and provide examples, as necessary. Use specific verbs of action, such as “manages”, “operates”, “analyzes”, “designs”, etc. Indicate three to five accountabilities in descending order of importance and approximate % of time spent on each.
？ To maintain and improve China commercial quality management system to ensure related quality processes are conducted effectively and ultimately fulfill the goal of best in class product quality, patient safety and regulatory compliance
？ To plan and lead the construction of QMS covering different legal entities of ThermoFisher China commercial.
？ Plan and organize ISO certification activities.
？ To lead or support process improvements and apply effective quality control for assigned partnering departments.
？ To fully utilize QMS to drive overall effectiveness of quality processes by in-house audit, CAPA, training, quality management review, change management, risk management, doc and records control, training, etc
？ To plan and deploy internal audit on both QMS and local regulations to ensure no surprises in external auditor inspection
？ To have regular review of QMS goals, focuses and structures, thus to improve overall quality system effectiveness
3. Experience: What unique knowledge are needed to successfully perform the job and what would you consider most skills are most desirable (e.g., sales experience, ability to operate within a marketplace that is complex, management skills etc), years of experience.
？ Health care industry 4+ years quality experience
？ 2+ years of practical medical device quality system management.
？ Comprehensive understanding and hands on experiences on ISO13485. Certified leader auditor is a plus.
？ Working knowledge of CFDA medical device GMP&GSP regulations and how to interpret and monitor them with experience or knowledge in Quality process relating to medical device GMP&GSP.
？ Rich experience for quality control on core GSP trading company functions as well as leading CAPA/process improvements.
？ Understanding and implementation experience in the following tools is preferred: FMEA, control plan design, process capability improvement, 5S, kaizen, kanban, value stream management, poka-yokes, etc.
4. Education (specific educational requirement or technical training, multi-language, Global, computer knowledge, etc)
？ The candidate should have a Bachelor’s Degree in related life science or advanced technical degree or equivalent.
5. Job Competencies: What competencies are needed to successfully perform the job (business Acumen, Negotiation Skills, etc)
？ Solid understanding on ISO 13485, China medical device GMP and GSP requirements.
？ Prior knowledge and understanding of the Medical Device/IVD or equivalent regulated industry
？ The ability to lead a cross-functional team is required.
？ Good discovery, analysis and problem solving skills
？ Familiar with six sigma concept and using ability is a plus
？ High responsibility, passion and self-motivation
？ Strong executive ability
？ Result-oriented
？ Have the consciousness of quality first and persist quality maxim
？ Fluent oral and written English
1. Position Summary: What is the main purpose of this job? Why does it exist? (e.g., to create marketing strategies; to develop, support and grow Compliance awareness etc.) Please summarize in two to three sentences.
？ The position will be responsible to establishing, maintaining and enhancing company’s Quality Management System with China commercial organization, in order to supervise all quality processes to ensure full compliance to regulatory and corporate quality requirements.
2. Principal Accountabilities: What are the key responsibilities of this job? List the what, how and why of each responsibility and provide examples, as necessary. Use specific verbs of action, such as “manages”, “operates”, “analyzes”, “designs”, etc. Indicate three to five accountabilities in descending order of importance and approximate % of time spent on each.
？ To maintain and improve China commercial quality management system to ensure related quality processes are conducted effectively and ultimately fulfill the goal of best in class product quality, patient safety and regulatory compliance
？ To plan and lead the construction of QMS covering different legal entities of ThermoFisher China commercial.
？ Plan and organize ISO certification activities.
？ To lead or support process improvements and apply effective quality control for assigned partnering departments.
？ To fully utilize QMS to drive overall effectiveness of quality processes by in-house audit, CAPA, training, quality management review, change management, risk management, doc and records control, training, etc
？ To plan and deploy internal audit on both QMS and local regulations to ensure no surprises in external auditor inspection
？ To have regular review of QMS goals, focuses and structures, thus to improve overall quality system effectiveness
3. Experience: What unique knowledge are needed to successfully perform the job and what would you consider most skills are most desirable (e.g., sales experience, ability to operate within a marketplace that is complex, management skills etc), years of experience.
？ Health care industry 4+ years quality experience
？ 2+ years of practical medical device quality system management.
？ Comprehensive understanding and hands on experiences on ISO13485. Certified leader auditor is a plus.
？ Working knowledge of CFDA medical device GMP&GSP regulations and how to interpret and monitor them with experience or knowledge in Quality process relating to medical device GMP&GSP.
？ Rich experience for quality control on core GSP trading company functions as well as leading CAPA/process improvements.
？ Understanding and implementation experience in the following tools is preferred: FMEA, control plan design, process capability improvement, 5S, kaizen, kanban, value stream management, poka-yokes, etc.
4. Education (specific educational requirement or technical training, multi-language, Global, computer knowledge, etc)
？ The candidate should have a Bachelor’s Degree in related life science or advanced technical degree or equivalent.
5. Job Competencies: What competencies are needed to successfully perform the job (business Acumen, Negotiation Skills, etc)
？ Solid understanding on ISO 13485, China medical device GMP and GSP requirements.
？ Prior knowledge and understanding of the Medical Device/IVD or equivalent regulated industry
？ The ability to lead a cross-functional team is required.
？ Good discovery, analysis and problem solving skills
？ Familiar with six sigma concept and using ability is a plus
？ High responsibility, passion and self-motivation
？ Strong executive ability
？ Result-oriented
？ Have the consciousness of quality first and persist quality maxim
？ Fluent oral and written English
职能类别： 体系工程师
公司介绍
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit ********************.
About Thermo Fisher Scientific China
Thermo Fisher Scientific (China) Co., Ltd has been operating in China for over 35 years. Headquartered in Shanghai, Thermo Fisher Scientific China has branch offices in Beijing, Guangzhou, Hong Kong, Chengdu, Shenyang, Xian, Nanjing, Wuhan, Kunming and other cities with around 4,000 employees. Our products mainly include analytical instruments, laboratory equipment, chemical reagents, consumables, software and more; providing comprehensive laboratory solutions and serving customers across various industries. In order to meet the local needs in China, we have established 6 manufacturing sites in Shanghai, Beijing and Suzhou respectively. We also have 5 application centers across the country which bring world-class technology and products with application development and training services to local customers. Lastly, we have the China Innovation Center in Shanghai which develops products according to local demands with global advanced technology. We have a nationwide maintenance network and China service training team, including over 2,000 professionals directly providing services for customers. We are committed to enabling our customers to make the world healthier, cleaner and safer. For more information, please visit ********************.
赛默飞世尔科技简介
赛默飞世尔科技（纽约证交所代码：TMO）是科学服务领域的世界领导者。公司年销售额超过200亿美元，在全球拥有约65,000名员工。我们的使命是帮助客户使世界更健康、更清洁、更安全。我们帮助客户加速生命科学领域的研究、解决在分析领域所遇到的复杂问题与挑战，促进医疗诊断发展、加速药物上市进程、提高实验室生产力。借助于首要品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific和Unity Lab Services，我们领先推出结合创新技术、便捷采购和全方位服务的整体解决方案。欲了解更多信息，请浏览公司网站：********************
赛默飞世尔科技中国简介
赛默飞世尔科技进入中国发展已超过35年，在中国的总部设于上海，并在北京、广州、香港、成都、沈阳、西安、南京、武汉、昆明等地设立了分公司，员工人数超过4000名。我们的产品主要包括分析仪器、实验室设备、试剂、耗材和软件等，提供实验室综合解决方案，为各行各业的客户服务。为了满足中国市场的需求，现有6家工厂分别在上海、北京和苏州运营。我们在全国还设立了5个应用开发中心，将世界级的前沿技术和产品带给中国客户，并提供应用开发与培训等多项服务；位于上海的中国创新中心结合中国市场的需求和国外先进技术，研发适合中国的技术和产品；我们拥有遍布全国的维修服务网点和特别成立的中国技术培训团队，在全国有超过2000名专业人员直接为客户提供服务。我们致力于帮助客户使世界更健康、更清洁、更安全。欲了解更多信息，请登录网站：********************
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit ********************.
About Thermo Fisher Scientific China
Thermo Fisher Scientific (China) Co., Ltd has been operating in China for over 35 years. Headquartered in Shanghai, Thermo Fisher Scientific China has branch offices in Beijing, Guangzhou, Hong Kong, Chengdu, Shenyang, Xian, Nanjing, Wuhan, Kunming and other cities with around 4,000 employees. Our products mainly include analytical instruments, laboratory equipment, chemical reagents, consumables, software and more; providing comprehensive laboratory solutions and serving customers across various industries. In order to meet the local needs in China, we have established 6 manufacturing sites in Shanghai, Beijing and Suzhou respectively. We also have 5 application centers across the country which bring world-class technology and products with application development and training services to local customers. Lastly, we have the China Innovation Center in Shanghai which develops products according to local demands with global advanced technology. We have a nationwide maintenance network and China service training team, including over 2,000 professionals directly providing services for customers. We are committed to enabling our customers to make the world healthier, cleaner and safer. For more information, please visit ********************.
赛默飞世尔科技简介
赛默飞世尔科技（纽约证交所代码：TMO）是科学服务领域的世界领导者。公司年销售额超过200亿美元，在全球拥有约65,000名员工。我们的使命是帮助客户使世界更健康、更清洁、更安全。我们帮助客户加速生命科学领域的研究、解决在分析领域所遇到的复杂问题与挑战，促进医疗诊断发展、加速药物上市进程、提高实验室生产力。借助于首要品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific和Unity Lab Services，我们领先推出结合创新技术、便捷采购和全方位服务的整体解决方案。欲了解更多信息，请浏览公司网站：********************
赛默飞世尔科技中国简介
赛默飞世尔科技进入中国发展已超过35年，在中国的总部设于上海，并在北京、广州、香港、成都、沈阳、西安、南京、武汉、昆明等地设立了分公司，员工人数超过4000名。我们的产品主要包括分析仪器、实验室设备、试剂、耗材和软件等，提供实验室综合解决方案，为各行各业的客户服务。为了满足中国市场的需求，现有6家工厂分别在上海、北京和苏州运营。我们在全国还设立了5个应用开发中心，将世界级的前沿技术和产品带给中国客户，并提供应用开发与培训等多项服务；位于上海的中国创新中心结合中国市场的需求和国外先进技术，研发适合中国的技术和产品；我们拥有遍布全国的维修服务网点和特别成立的中国技术培训团队，在全国有超过2000名专业人员直接为客户提供服务。我们致力于帮助客户使世界更健康、更清洁、更安全。欲了解更多信息，请登录网站：********************
联系方式
- Email：jiaqi.zheng@thermofisher.com
- 公司地址：新金桥路27号3&6&7号楼