OVERALL PURPOSE OF ROLE岗位总体目标:

• Support the product and process quality control and improvement.

  支持产品和流程品质管控和改善

• To work with supplier to handle the NMR and supplier quality performance improvement for Suzhou plant.

  和供应商合作处理NMR并改善供应商品质

• To support the quality control to a contracted warehouse to meet CFDA regulation.

  支持外仓管控，确保外仓品质管控符合CFDA法规要求

• To support the customer complaint handle from China market as China market grows fast.

  对中国市场客户投诉进行处理

• Support quality management system maintenance and improvements.

  支持品质体系维护和改善

ESSENTIAL DUTIES AND RESPONSIBILITIES 主要岗位职责:

• 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）

• To identify risks with the team members, define suitable measures for risk reduction and control the process;

和团队合作识别风险，并使用合适的错输降低风险，控制流程

• To plan and deploy necessary process controls in the series production;

在生产过程中，策划并展开过程管控

• To support customer quality management to investigate root causes and implement corrective & preventive actions when customer complaints;

当客户投诉时，支持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 Welch Allyn Medical products;

制作对公司产品成品质量检查计划和测试计划

• To create incoming goods quality check plan in SAP;

在SAP中建立进料检验计划.

• To make out the test plan base on product SPEC and assure that products tested are made to expected quality standards

按照产品标准制定测试计划，保证产品的测试按照预期的质量标准进行.

• Detect and analyze problems, and make recommendations on how to correct them and follow up with corrective action and preventive measures for internal manufacturing quality and customer complaints

观测分析内部质量问题和客户投诉，推荐纠正措施，并落实纠正预防措施的实施.

• 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

• Interface with manufacturing / engineering management to solve product / process quality problems

与制造/工程管理合作解决产品或流程问题

• Proactive factory and field component defect reduction and quality improvement

积极减少工厂和市场端的不良和改善品质

• 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

• Quality improvement leadership with Welch Allyn suppliers, contract manufacturers, design engineers, sourcing engineers, and manufacturing engineers

带领Welch Allyn的供应商，代工厂商，设计工程师，测试工程师，采购工程师和制造工程师进行改善

• Point of escalation to drive product failure analysis, containment actions, and corrective actions

提出需要产品不良分析，围堵措施和纠正措施

• 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)

• SAP Material Master Data Maintenance

SAP 物料主数据维护

• Quality information record maintenance

质量信息记录维护

• New product / production line qualification

新产品或者产线认证

Requirements for jobholder 岗位要求:

• ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) preferred

最好有ASQ认证 (CQE, CQA)

• Experience of SAP is preferred

SAP经验优先

• 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)

  最好有关于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）。

• 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

• Demonstrates high level of engagement, and self-starter attitude, good negotiator

  有很好地参与精神，具有从我做起的能力，具有很好地谈判能力

• 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

EDUCATION AND/OR EXPERIENCE 教育经验:

• 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 5 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，最好有医疗相关行业经验。有很好的产品知识，包括装配方面的知识

上班地址：锦峰路8号江苏医疗科技产业园9号楼3楼

关于Hill-Rom
Hill-Rom是全球领先患者护理产品和服务的供应商，为急症护理，长期护理和家庭护理环境提供各种产品和服务。Hill-Rom所提供的产品和服务包括：设施评估、患者护理病床、担架、治疗床垫、序贯性挤压治疗装置、护士通讯系统、工作流程系统、病床床头医疗设备带系统和病房家具。

2000年7月19日，美国屹龙国际有限公司上海代表处(Hill-Rom International,Inc.Shanghai Rep Office)在上海注册成立。主要负责中国地区的产品推广和售后服务。随着公司业务的发展，2013年9月27日我们在上海注册成立了熠隆医疗设备（上海）有限公司(Hill-Rom Shanghai Ltd.)。

2005年4月15日，屹龙商务服务（苏州）有限公司(Hill-Rom Business Service Suzhou Co.,Ltd.)在苏州工业园区注册成立，作为Hill-Rom集团在亚太区设立的第一个国际供应链管理中心，公司目前正着力于进行电子类、机电类、金属件、塑胶件 等原材料的采购。

作为业界的领导者，Hill-Rom为员工提供了具有挑战性的工作体验、温馨友善的工作环境和完善的福利待遇。然而，就最重要的原因而言，选择在Hill-Rom工作就意味着员工有机会将他们的真诚和热忱投入工作中，创造不平凡的业绩。

Hill-Rom的愿景，使命以及核心价值观
MISSION
Every day, around the world, we enhance outcomes for our patients and their caregivers.
VISION
We will be a $5 billion global medical technology leader providing the best solutions for our patients and caregivers, and the best opportunities for our employees.
VALUES
Respect, responsiveness, results, integrity, fun

获得更多信息请登录 www.hill-rom.com.