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(yōu)質(zhì)生活”領(lǐng)域的多元化公司，致力于在醫(yī)療保健、優(yōu)質(zhì)生活和照明領(lǐng)域，用有意義的創(chuàng)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(wù)網(wǎng)絡(luò)遍布世界100多個(gè)國(guó)家，2012年的銷售額達(dá)248億歐元，并在心臟監(jiān)護(hù)、緊急護(hù)理和家庭醫(yī)療保健、節(jié)能照明解決方案和新型照明應(yīng)用、以及男性剃須和儀容產(chǎn)品、家居和便攜式娛樂產(chǎn)品以及口腔護(hù)理產(chǎn)品等領(lǐng)域均居于世界領(lǐng)先地位。
醫(yī)療保健
作為醫(yī)療保健領(lǐng)域的全球領(lǐng)導(dǎo)者，我們始終秉承“以人為本”的理念，致力于通過創(chuàng)新讓世界更加健康，以創(chuàng)新的醫(yī)療解決方案來提升和拓展全球的醫(yī)療護(hù)理，為患者打造理想的產(chǎn)品體驗(yàn)。

我們?yōu)榕R床醫(yī)生和廣大醫(yī)務(wù)工作者提供一站式醫(yī)療信息系統(tǒng)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(jìn)的產(chǎn)品和解決方案，幫助臨床醫(yī)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(dòng)和遠(yuǎn)程技術(shù)，不斷在提升醫(yī)療保健系統(tǒng)效率方面創(chuàng)新，讓更多的人享受到優(yōu)質(zhì)醫(yī)療服務(wù)。

這些承諾都促使我們加大研發(fā)力度，努力在放射學(xué)、心臟病學(xué)、腫瘤學(xué)、決策支持、家庭醫(yī)療保健、以及呼吸道疾病等主要疾病的治療方面持續(xù)創(chuàng)新。
我們通過四大戰(zhàn)略業(yè)務(wù)部門來開展醫(yī)療保健業(yè)務(wù)，即影像系統(tǒng)、監(jiān)護(hù)治療和臨床信息、家庭醫(yī)療保健解決方案和客戶服務(wù)。

飛利浦醫(yī)療保健事業(yè)部在全球擁有約37,400名員工。
優(yōu)質(zhì)生活
在優(yōu)質(zhì)生活事業(yè)部，我們繼續(xù)履行飛利浦的發(fā)展愿景，旨在通過創(chuàng)新改善世界人口的健康狀況，并促進(jìn)世界的可持續(xù)發(fā)展。我們的足跡遍及全球，在成熟和成長(zhǎng)型市場(chǎng)均已建立了業(yè)務(wù)網(wǎng)絡(luò)。我們加大創(chuàng)新投資并實(shí)施業(yè)務(wù)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(lǐng)先，深受世界信賴。
飛利浦優(yōu)質(zhì)生活圍繞業(yè)務(wù)和市場(chǎng)，致力于通過品類開發(fā)和卓越的營(yíng)運(yùn)來創(chuàng)造價(jià)值。
我們通過“業(yè)務(wù)市場(chǎng)整合”（BMC）來制定計(jì)劃、配置資源和實(shí)施管理。在經(jīng)營(yíng)過程中，我們實(shí)行明確的責(zé)任制，使決策更貼近客戶和市場(chǎng)的需求，從而激發(fā)了企業(yè)家精神，加快了業(yè)務(wù)發(fā)展的步伐。
我們的重點(diǎn)業(yè)務(wù)領(lǐng)域包括：健康護(hù)理、個(gè)人護(hù)理和廚房電器及家居護(hù)理。
飛利浦優(yōu)質(zhì)生活事業(yè)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(yè)的領(lǐng)導(dǎo)者，我們?cè)趧?chuàng)新照明解決方案的開發(fā)、制造和應(yīng)用領(lǐng)域享有行業(yè)公認(rèn)的專業(yè)地位。在過去的121年中，我們?cè)谡彰黝I(lǐng)域銳意創(chuàng)新，取得了多項(xiàng)重大的革命性成果，為公司今日的領(lǐng)導(dǎo)地位奠定了堅(jiān)實(shí)基礎(chǔ)，并幫助我們成為數(shù)字化照明轉(zhuǎn)型時(shí)代的領(lǐng)袖。未來我們將加大在LED照明領(lǐng)域的投資，并利用我們?cè)趥鹘y(tǒng)照明領(lǐng)域豐富的產(chǎn)品組合、分銷網(wǎng)絡(luò)和品牌優(yōu)勢(shì)，進(jìn)一步鞏固我們?cè)跀?shù)字照明市場(chǎng)的領(lǐng)先地位。
我們能夠在各類細(xì)分市場(chǎng)上滿足人們的照明需求。在室內(nèi)照明方面，我們?yōu)榧彝ァ⑸虉?chǎng)、辦公室、學(xué)校、酒店、工廠和醫(yī)院提供照明解決方案。在室外照明方面，我們?yōu)槌鞘芯坝^、道路（包括街道照明和汽車照明）、公共空間、居民區(qū)和運(yùn)動(dòng)場(chǎng)所提供照明解決方案。此外，我們還為園藝和水凈化等專業(yè)領(lǐng)域提供定制化的照明應(yīng)用方案。
飛利浦照明擁有光源電子，消費(fèi)燈具，專業(yè)照明解決方案，汽車照明和Lumileds五大核心業(yè)務(wù)，覆蓋了整個(gè)照明產(chǎn)業(yè)鏈——從光源，燈具，電子和控制，到整體照明應(yīng)用與解決方案。
飛利浦照明事業(yè)部全球雇員人數(shù)約為50, 200人。