Healthcare - Complaint Handling Unit Engineer

Department/Group: Quality and Regulatory Department
Address: Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industry Park, Suzhou, Jiangsu Province,

JOB DESCRIPTION

Main purpose of the role
• Maintain the quality management system compliance by ensuring the quality procedures are implemented and followed.
• Concentrate on CFR820.198 complaint files, 820.803 MEDICAL DEVICE REPORTING, 820.806 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS and ISO13485 7.2.3
• Handling complaints from Installed Base, and adverse event reporting.
• Creating Field Action document package and performing Field action reporting to Marketing Authority in time.

Organisation context of role
a. Products/services:
• Products are image diagnostic medical device, such as CT, MR, DXR, ultrasonic, and their components and accessary.
• Setting up quality system is the foundation for a medical device company to start operation. Also compliance to regulatory agencies’ requirements is the must for a medical device company to stay in business.
b. Position in value chain:
• Internal: major functions such as R&D, manufacturing, purchasing etc
• External: regulatory agencies such as US FDA, China CFDA and notify bodies such as TUV
c. Other relevant organisational aspects: (e.g. diversity of the business; acquisitions/ventures; geographical spread; risk; dynamics of the organisation and market; the complexity of the technologies used; the innovation of the products, etc. etc.).
• Philips Healthcare (Suzhou) Co., Ltd is a brand new facility therefore a new QMS needs to be in place to support that.
• We focus on the China Domestic market, but also provide products to international markets.

Reporting and other significant organisational relationships
• Reporting Relationship: Sr. Quality System Manager
• Peers: : Mainly the Q&R team and Q&R colleagues in other BUs across IS business group.
• Other significant relationships – internal: Complaint review board, adverse event report review board, and field action review board, Internal quality system audit meetings, Cross functional improvement meetings, defect tracking meetings, CAPA
• Other significant relationships – external: Customer Audit, Notified body (TUV) audit, China CFDA and US FDA inspections

Key areas of accountability
• Responsible for customer complain handling by interface with field service
• Drive the customer complaint resolve by working with cross functions
• Responsible for adverse event reporting to applicable Authority Competency
• Evaluate the risk level with R&D team for complaint hazardous situation per Product Risk Management Files
• Drive Complaint process and implementation
• Issue field action document package with LCM team, and perform the field action reporting to competency authority.
• Organize Complaint periodic review and work with cross function to facilitate Complaint closure
• Organize Quality Training and conduct quality training as needed
• Support QMS manager to promote Quality Culture
• Quality statistic, Analysis and process improvement

Job Holder’s Profile Requirements
• BS/MS in Engineering or equivalent experience
• Strong quality assurance management experience, minimum 5 years
• Strong Post Market surveillance and experience
• Strong statistical and analytical abilities.
• Six Sigma Black Belt is preferred
• Image System Product service experience is preferred
• Strong communication, problems solving and continuous improvement.
• Fluent English both in writing and speaking.
• Have experience in medical industry is plus

荷兰皇家飞利浦电子公司是一家“健康舒适、优质生活”领域的多元化公司，致力于在医疗保健、优质生活和照明领域，用有意义的创新来改善人们的生活。总部位于荷兰的飞利浦公司在全球拥有大约118,000名员工，销售和服务网络遍布世界100多个国家，2012年的销售额达248亿欧元，并在心脏监护、紧急护理和家庭医疗保健、节能照明解决方案和新型照明应用、以及男性剃须和仪容产品、家居和便携式娱乐产品以及口腔护理产品等领域均居于世界领先地位。
医疗保健
作为医疗保健领域的全球领导者，我们始终秉承“以人为本”的理念，致力于通过创新让世界更加健康，以创新的医疗解决方案来提升和拓展全球的医疗护理，为患者打造理想的产品体验。

我们为临床医生和广大医务工作者提供一站式医疗信息系统解决方案，充分利用临床信息，使诊断更有把握，工作更加高效。
我们正致力于提供最先进的产品和解决方案，帮助临床医生诊断、治疗和管理目前最常见的一些疾病。
我们通过使用新的移动和远程技术，不断在提升医疗保健系统效率方面创新，让更多的人享受到优质医疗服务。

这些承诺都促使我们加大研发力度，努力在放射学、心脏病学、肿瘤学、决策支持、家庭医疗保健、以及呼吸道疾病等主要疾病的治疗方面持续创新。
我们通过四大战略业务部门来开展医疗保健业务，即影像系统、监护治疗和临床信息、家庭医疗保健解决方案和客户服务。

飞利浦医疗保健事业部在全球拥有约37,400名员工。
优质生活
在优质生活事业部，我们继续履行飞利浦的发展愿景，旨在通过创新改善世界人口的健康状况，并促进世界的可持续发展。我们的足迹遍及全球，在成熟和成长型市场均已建立了业务网络。我们加大创新投资并实施业务本地化，这使得我们能够提供源源不断的、符合本土需求的、有意义的解决方案。我们的品牌全球领先，深受世界信赖。
飞利浦优质生活围绕业务和市场，致力于通过品类开发和卓越的营运来创造价值。
我们通过“业务市场整合”（BMC）来制定计划、配置资源和实施管理。在经营过程中，我们实行明确的责任制，使决策更贴近客户和市场的需求，从而激发了企业家精神，加快了业务发展的步伐。
我们的重点业务领域包括：健康护理、个人护理和厨房电器及家居护理。
飞利浦优质生活事业部在全球拥有近18,900名员工。
照明
飞利浦照明是全球照明行业的领导者，我们在创新照明解决方案的开发、制造和应用领域享有行业公认的专业地位。在过去的121年中，我们在照明领域锐意创新，取得了多项重大的革命性成果，为公司今日的领导地位奠定了坚实基础，并帮助我们成为数字化照明转型时代的领袖。未来我们将加大在LED照明领域的投资，并利用我们在传统照明领域丰富的产品组合、分销网络和品牌优势，进一步巩固我们在数字照明市场的领先地位。
我们能够在各类细分市场上满足人们的照明需求。在室内照明方面，我们为家庭、商场、办公室、学校、酒店、工厂和医院提供照明解决方案。在室外照明方面，我们为城市景观、道路（包括街道照明和汽车照明）、公共空间、居民区和运动场所提供照明解决方案。此外，我们还为园艺和水净化等专业领域提供定制化的照明应用方案。
飞利浦照明拥有光源电子，消费灯具，专业照明解决方案，汽车照明和Lumileds五大核心业务，覆盖了整个照明产业链——从光源，灯具，电子和控制，到整体照明应用与解决方案。
飞利浦照明事业部全球雇员人数约为50, 200人。