ESSENTIAL DUTIES AND RESPONSIBILITIES: 主要工作职责
· To identify necessary quality requirements (Listing of Requirements) for new project/product.
对新产品或项目定义品质标准要求（要求清单）
· Responsible for customer quality management to investigate root causes and implement corrective & preventive actions when customer complaints.
当客户投诉时，负责客户品质管理对原因调查并执行纠正预防措施;
· To build quality check and performance tests plans on finished Trumpf Medical products.
制作对公司产品成品质量检查计划和测试计划
· Monitor process and product quality performance and lead actions when necessary.
监控过程和产品品质水平，并在必要时实施措施
· Understand failure mechanisms across product line, identify root causes, follow through the implementation of corrective actions and the development of preventative actions
理解生产线的实效模式，确定根本原因，使用纠正措施和预防措施跟进
· Cooperate with regional supplier quality, participate in the management and maintenance of local supplier quality system.
与区域供应商质量合作，参与管理维护本地供应商质量体系
· Offer training to quality staff (Inspection method, plan and criteria)
为质检人员提供培训(检验方法，计划及标准)
· Other duties may be assigned.
其他可能被安排的工作。
EDUCATION AND EXPERIENCE: 教育背景及工作经验
· Bachelor’s degree is preferred
本科学历优先
· majoring mechanical,or related engineering
机械工程或相关专业
· Experience in quality control with a minimum of 8 – 10 years’ experience, preferred in medical industry. Must have extensive product knowledge, including mechanical assembly
从事质量控制工作至少5年以上，***有医疗相关行业经验。有很好的产品知识，包括机械装配方面的知识
· ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) preferred
***有ASQ认证 (CQE, CQA)
QUALIFICATIONS AND SKILLS: 任职资格及技能
· Experience of SAP is preferred
SAP经验优先
· Computer competency in Word, Excel, Power Point and database. Can use outlook.
具有office软件工具能力, 会使用outlook
· Good working knowledge of PFMEA, FAI, Control Plan
有PFMEA, FAI 和Control plan 的经验
· Working knowledge of FDA, CFDA and GMP is highly preferred. Must have working knowledge of standard quality system requirements (such as ISO 9001, ISO 13485, Medical Device Directive, Canadian Medical Device Regulation)
***有关于FDA，CFDA和GMP的工作经验。必须要有关于标准品质体系要求的工作经验(如ISO9001，ISO13485，MDD，CMDR) 的工作经验
· Must be familiar with documentation, drawings, schematics, parts list (German and English), knowledge of total inspection techniques (metric and standard). 熟悉技术文件图纸，图标，零件清单，有检验技能（公制，标准）。
· Have knowledges of all facets of machinery: i.e. mechanical, hydraulic, pneumatic, High/low voltage electric, software, machine operations, applications
具备机械方面的综合知识，机械传动，液压，气动，高低压电气，软件，机器操作和使用等
· Demonstrated strong analytical problem solving, teaming and communications, interpersonal skills.
有很强的问题分析解决能力，团队合作沟通和人际交往能力
· Practical experience in metrology, test, inspection and analysis techniques
有关于计量、测试、检查和分析技术的实践经验
· Have thorough knowledge of quality tools to drive quality improvement professionally
可以很好地使用质量工具来推动质量改进
· Loyal and discreet, easy to work with, intuition towards others
忠诚谨慎，容易相处，为人正直
· Willing to take on responsibility and high-level deliverability
愿意积极负责，并可以达成预期的成果