杭州招聘

Position Summary:

Responsible for daily product complaint handling, AE handling, Field action implementation, periodical risk evaluation report. Complete data analysis periodically.

Major responsibilities:

Complaint handling:

• Work with local cross function team on complaint initial investigation and improvement closely. Be responsible for complaint handled in a time manner, Monitor the actions from complaint investigation implementation progress and give feedback in timely manner.
• Data intelligence and trending report to drive continuous improvement.
• Prepare report of complaint data analysis and report of effectiveness of complaint handling process for management review.

Adverse Event Handling and Management

• Ensure all adverse events including local and oversea AE reporting are handled in timely manner and comply with requirement of regulation.
• Work with China RA, global RAQA complete periodical risk assessment report. Endure all PRER submit on time per NMPA requirements.
• Liaison with the Competent Authority.

Recall & FCA management

• Coordinate overall recall process to comply with China recall regulations
• Coordinate or establish communication material for recall;
• Lead the cross-functional team to handle all the recalls in timely manner
• Liaison with the Competent Authority and work out the report by the requirement of regulation

BU quality partner

• Act as major contact window to BU for Quality related inquiry when there is no defined process to address
• Relay specific inquiries to correspondent quality Subject Matter Experts
• Participate in BU biz and quality review to understand BU strategies and initiatives
• Provide professional advice for BU strategies and initiatives from quality perspective
• Provide Quality training and strategic communication to BU

Basic qualification requirements:

• Bachelor’s degree, degree in related life science or advanced technical degree or equivalent is preferred
• Strong understanding on China medical device applicable regulations such as GMP, GSP etc.
• PMS experience in China Medical device trading company 3+ years of quality experience
• 6+ years of working experience as quality professional in medical device industry, where 3+ years as manufacturing quality professional and 3+ years as trading company quality professional.
• The ability to work with cross-functional team
• Fluent oral and written English
• Understanding and implementation experience of six sigma or quality tools is preferred

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

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, Xi’an, Nanjing, Wuhan, Jinan, and Dongguan with around 5,000 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 8 manufacturing sites in Shanghai, Beijing, Suzhou and Guangzhou respectively. We also have 6 application centers and demo labs 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 and Suzhou, with over 100 scientists & engineers and more than 100 patents. China Innovation Center focuses on research and development supporting key vertical markets and develops products according to local demands with global advanced technologies. We have a nationwide maintenance network and China service training team, including over 2,800 professionals directly providing services for customers.
We are committed to enabling our customers to make the world healthier, cleaner and safer.

赛默飞世尔科技简介
赛默飞世尔科技是科学服务领域的世界领导者。公司年销售额超过300亿美元。
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、促进医疗诊断和治疗的发展、提高实验室生产力。
我们全球超过80,000名赛默飞员工将借助于一系列行业领先的品牌Thermo Scientific、Applied Biosystems、Invitrogen、Fisher Scientific、Unity Lab Services和Patheon，为客户提供领先的创新技术、便捷采购方案和全方位服务。

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、济南、东莞等地设立了分公司，员工人数约为5000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8家工厂分别在上海、北京、苏州和广州等地运营。我们在全国还设立了6个应用开发中心以及示范实验室，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；位于上海和苏州的中国创新中心，拥有100多位专业研究人员和工程师及100多项专利。创新中心专注于垂直市场的产品研究和开发，结合中国市场的需求和国内外先进技术，研发适合中国用户的技术和产品；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2800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。