长沙招聘

Department: Quality
Location: Shanghai, CMC
Reporting Relationships:
Reports to: Quality and Compliance Director
Essential Duties and Responsibilities
-Manages ISO 9001 Quality System for GCMS Business Unit, which includes facilitating internal audits and reporting on the internal audit quality system.
-Establishes, monitors, and presents quality metrics for product improvement teams
communicating potential key product quality issues to management
participating in Change Control Reviews as a technical resource
and updating Quality Assurance Procedures.
-Lead bi-weekly Quality reviews with overseas manufacturing facilities to ensure product quality meets targets and appropriate actions are driven when targets are not achieved.
-Represents Quality on new product development teams. This role ensures adequate Quality Plans are defined and Quality deliverables are executed.
-Receiving and First Article Inspection requirements are defined & executed by appropriate personnel.
-Uses statistical techniques such as DOE, SPC, Gage R&R, and capability studies to improve designs, analyze problems and monitor processes.
-Additionally, this role may lead FMEA activities, audit new suppliers, and ensure the product developed meets customer expectations through the development and execution of process / product validation plans and control plans.
-Facilitates forums for gathering the appropriate technical expertise when required for root cause analysis and corrective actions to be determined.
-Responsible for, or supports, acquisition of the product & process quality data and the creation and publication of Quality Reports
-Provides leadership in the Material Review and Change Control boards. This involves driving appropriate actions to ensure containment and communications are agreed upon for quality issues and engineering change orders (ECOs).
-Provides training and support on Quality Systems, as well as monitors for adherence to the quality program.
Decision Making Authority
-Authorize shipment based on test results.
-Modify schematics to recommend changes for engineering improvements under the guidance and approval of R&D
-Lead Material Review Board for decisions on material > $1000 scrap cost
-Reject defective material with a recommendation for disposition
-All expenses for Purchasing card must be approved before purchase.
Specific Scope Data
-Monitors key Customer facing metrics, such as Customer Allegiance, Warranty, Installation Excellence, and drives actions according to business priorities to ensure Quality goals are achieved.
Minimum Education and Experience Requirements
-Bachelor’s degree in a technical field from an accredited college or university required, or equivalent experience with a 2 year degree
-Minimum five years of experience in the quality profession required, which may include Quality Engineering, Process Engineering, or Manufacturing Engineering with responsibilities pertaining to product quality and/or process improvement. Experience should include practical application of SPC, DOE, continuous improvement tools, Lean tools, and auditing
-Previous experience in an ISO 9001 environment required
-Certified Quality Engineer (CQE) or Six-Sigma Black Belt (SSBB) preferred
Knowledge, Skills, and Abilities necessary to perform essential functions
Required
-Demonstrate Thermo Fisher Scientific values – Integrity, Intensity, Innovation and Involvement
-Initiative and self-direction in planning, organizing, documenting and solving problems.
-Technical expertise to identify root cause through data analysis and implement corrective action using 8-D methodology
-Ability to evaluate product and process change requests to ensure product quality is not compromised.
-Working knowledge of the ISO 9001 standards and be capable of developing and auditing procedures that comply with the standards.
-Working knowledge of statistical concepts such as Gage R&R, Capability Studies, SPC, DOE.
-Experience leading SPAP/PPAP and D/PFMEAs
-Ability to work with mathematical concepts such as probability and statistical inference.
Preferred
-Effective presentation skills
-Working knowledge of ISO 13485 standard
Interaction with Other Employees (level of contact, purpose and frequency):
The Senior BU Quality Engineer provides leadership to the entire GCMS business unit in this unique role. This position oversees the key quality activities across a global team comprised of two manufacturing locations, two R&D locations, and a world-wide support structure for services. Critical responsibilities include sustaining the ISO 9001 BU Quality System, NPI/NPD oversight of quality deliverables, identifying key projects based on Customer and business needs, and acting as lead for resolving quality issues. Typical responsibilities also include conducting supplier and internal process audits, implementing and monitoring use of statistical quality tools, and standard reporting.
职位要求：
同上

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。