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

荷蘭皇家飛利浦電子公司是一家“健康舒適、優質生活”領域的多元化公司，致力于在醫療保健、優質生活和照明領域，用有意義的創新來改善人們的生活。總部位于荷蘭的飛利浦公司在全球擁有大約118,000名員工，銷售和服務網絡遍布世界100多個國家，2012年的銷售額達248億歐元，并在心臟監護、緊急護理和家庭醫療保健、節能照明解決方案和新型照明應用、以及男性剃須和儀容產品、家居和便攜式娛樂產品以及口腔護理產品等領域均居于世界領先地位。
醫療保健
作為醫療保健領域的全球領導者，我們始終秉承“以人為本”的理念，致力于通過創新讓世界更加健康，以創新的醫療解決方案來提升和拓展全球的醫療護理，為患者打造理想的產品體驗。

我們為臨床醫生和廣大醫務工作者提供一站式醫療信息系統解決方案，充分利用臨床信息，使診斷更有把握，工作更加高效。
我們正致力于提供最先進的產品和解決方案，幫助臨床醫生診斷、治療和管理目前最常見的一些疾病。
我們通過使用新的移動和遠程技術，不斷在提升醫療保健系統效率方面創新，讓更多的人享受到優質醫療服務。

這些承諾都促使我們加大研發力度，努力在放射學、心臟病學、腫瘤學、決策支持、家庭醫療保健、以及呼吸道疾病等主要疾病的治療方面持續創新。
我們通過四大戰略業務部門來開展醫療保健業務，即影像系統、監護治療和臨床信息、家庭醫療保健解決方案和客戶服務。

飛利浦醫療保健事業部在全球擁有約37,400名員工。
優質生活
在優質生活事業部，我們繼續履行飛利浦的發展愿景，旨在通過創新改善世界人口的健康狀況，并促進世界的可持續發展。我們的足跡遍及全球，在成熟和成長型市場均已建立了業務網絡。我們加大創新投資并實施業務本地化，這使得我們能夠提供源源不斷的、符合本土需求的、有意義的解決方案。我們的品牌全球領先，深受世界信賴。
飛利浦優質生活圍繞業務和市場，致力于通過品類開發和卓越的營運來創造價值。
我們通過“業務市場整合”（BMC）來制定計劃、配置資源和實施管理。在經營過程中，我們實行明確的責任制，使決策更貼近客戶和市場的需求，從而激發了企業家精神，加快了業務發展的步伐。
我們的重點業務領域包括：健康護理、個人護理和廚房電器及家居護理。
飛利浦優質生活事業部在全球擁有近18,900名員工。
照明
飛利浦照明是全球照明行業的領導者，我們在創新照明解決方案的開發、制造和應用領域享有行業公認的專業地位。在過去的121年中，我們在照明領域銳意創新，取得了多項重大的革命性成果，為公司今日的領導地位奠定了堅實基礎，并幫助我們成為數字化照明轉型時代的領袖。未來我們將加大在LED照明領域的投資，并利用我們在傳統照明領域豐富的產品組合、分銷網絡和品牌優勢，進一步鞏固我們在數字照明市場的領先地位。
我們能夠在各類細分市場上滿足人們的照明需求。在室內照明方面，我們為家庭、商場、辦公室、學校、酒店、工廠和醫院提供照明解決方案。在室外照明方面，我們為城市景觀、道路（包括街道照明和汽車照明）、公共空間、居民區和運動場所提供照明解決方案。此外，我們還為園藝和水凈化等專業領域提供定制化的照明應用方案。
飛利浦照明擁有光源電子，消費燈具，專業照明解決方案，汽車照明和Lumileds五大核心業務，覆蓋了整個照明產業鏈——從光源，燈具，電子和控制，到整體照明應用與解決方案。
飛利浦照明事業部全球雇員人數約為50, 200人。