岗位职责和要求：
Title: Supplier Quality Engineer
Department: WW Supplier Quality
Location: MD&D Campus Suzhou travel in the Region and Worldwide
Reports to (Title): Manager, Supplier Quality (Cork, Ireland)
SCOPE OF THE ROLE AND BASIC PURPOSE
Implementation of quality systems to support outsourcing medical devices.
Minimize risk and assure quality levels are maintained.
Ensure quality, operational, process improvement and product development/transfer projects are implemented in an efficient and effective manner.
Provide quality leadership for the outsourcing of both components and finished devices to suppliers and External Manufacturers (EMs). Ownership will include supplier manufacturing through final release to distribution and response to field complaints of the finished devices.
Conduct on-site quality and process assessments at suppliers and EM's both to approve new suppliers and monitor existing suppliers
Generate quality metrics on supplier performance and establish measures to monitor quality costs and avoidances
Manage and maintain the technical qualifications of suppliers and supplier processes, and supervise the resolution of technical issues, which may arise.
Participates in designing, developing and executing design and manufacturing process validations/verifications and determines appropriate sampling plans or proactive initiatives for subsequent routine production.
Participates in pre-production activities for new and transferred products.
Produce advanced quality planning documentation with suppliers
Conduct process capability studies on supplier processes
Drive cost improvement with the use of PE tools
Develop and manage First Article Inspections as required at suppliers or within DePuy
Develop supplier capability in risk assessment such as PFMEA
Manage training and certification of operators and inspectors to CTQs with the suppliers as required
Develop and implement efficient and effective inspection points and control plans at the supplier that will provide STS status
KEY RESPONSIBILITIES / TASKS (indicate estimated % of time spent where possible)
Work with Quality, Procurement, EMs/Suppliers and Manufacturing
1.25% Conduct supplier qualification activities
2.25% Manage the qualification of supplier products and processes.
3.25% Analyze and resolve technical issues
4.25% Initiate and manage proactive improvement projects such as process excellence (six sigma) and other types of projects to improve quality, yields and value received from the supply base.
ACCOUNTABILITIES / KEY MEASURES
Manufacturing Support production-related issues attributed to suppliers
Engineering Support product development and sustaining engineering activities
Quality Assurance Partner with QA to ensure product quality at incoming inspection
Regulatory Compliance Partner with RC to ensure that the department and suppliers are in compliance with all applicable regulations
New Product Planning Support the product development process as appropriate
Suppliers Assess new/existing suppliers, qualify processes and assess technical capabilities
Type of Experience:
7 10 years working experience.
The holder of this role must have had previous manufacturing background.
Individual must have knowledge of medical device regulations and GMPs.
Preference is given to a candidate of Chinese nationality. Travel is required for this position.
University Degree Engineering
Have the training of Manufacturing of Medical Devices knowledge Suppliers development skills.
Excellent English Speaker/Writer
Fluent oral/written Chinese
Internal/External Auditor Certification
Following will be a plus:
Post Graduate Technical Degree
Six Sigma
Required Competencies and Skills:
Strong code of ethics
Excellent communication and presentation abilities
Demonstrated process/product validation knowledge
Project management skills
Ability to interpret, communicate and work from drawings and specifications
PC-based business software
Manufacturing knowledge in areas of plastics, metals and packaging.

美国强生公司成立于1886年，是目前世界上规模最大、产品种类最多的医疗保健公司之一。公司的主要业务分为3部分，即医疗和诊断器械、日用消费品及药品。强生公司在57个国家拥有200多家分公司，全球员工总数超过11万，2005年在全世界170多个国家和地区市场的销售收入达到505亿美元，其中医疗和诊断器械业务所占比例近40％。作为一家拥有百年悠久历史的企业，强生公司长期以来一直保持着高速的增长发展势头，跻身世界500强企业排名超过半个世纪，并多次被《财富》杂志等媒体评为“最受赞赏公司”、“最佳雇主”。 自1943年首次发布企业信条起，强生公司一直在全球业务范围和经营活动中坚持履行贯彻其信条，将信条作为公司的价值理念和一切工作的指导原则。简单概括起来，强生公司的信条就是如下四点： ·对顾客负责 ·对员工负责 ·对社会负责 ·对股东负责 每一名员工自加入公司起就随时铭记该信条，对信条的坚持时时刻刻贯穿融入到了公司工作的每一个环节和方面。强生公司之所以能在过去的漫长岁月中不断取得如此大的成就和发展，很大程度上就归功于对信条的贯彻执行。在医疗和诊断器械领域，强生公司雄踞全球第一的领导者地位，在其全部产品种类中，有超过70％的产品占有的市场份额排名在世界第一或第二。目前在该领域，强生公司共有10大类主要品牌和产品。 强生公司一直非常关注飞速发展的中国经济和中国市场。早在改革开放之初的1982年，强生公司就在北京成立了第一个代表处。1985年，强生在西安开办了其在中国大陆的第一家企业－西安杨森制药有限公司。随后，强生在中国大陆投资创办了一系列合资或独资企业，包括强生（中国）医疗器材有限公司、上海强生制药有限公司、强生（中国）有限公司等。基于在中国投资项目的成功以及对未来中国经济和市场发展的良好预期，促使强生公司决定进一步扩大在华投资规模。为了有效满足亚太和中国市场的需求及降低成本，强生公司决定在中国苏州新建一个医疗和诊断器械生产园区，将相当数量的产品转移至中国生产并供应全球市场。待全部建成后，该园区将成为强生在全球最大的生产基地之一，同时容纳多个品牌的医疗和诊断器械产品的生产。.