崗位責(zé)任l 制定和維護(hù)整個(gè)公司質(zhì)量體系，保證遵守iso13485，fda的qsr，加拿大的cmdcas的規(guī)范.2 教育，培訓(xùn)，及給員工提供意見(jiàn)，以確保質(zhì)量和監(jiān)管要求。進(jìn)行市場(chǎng)宣傳材料的審查。審計(jì)業(yè)務(wù)單位保證合規(guī)性和一致性，跟蹤和解決觀察到的可能導(dǎo)致不合規(guī)，或給用戶的帶來(lái)安全風(fēng)險(xiǎn)的趨勢(shì)。審查，批準(zhǔn)和保持系統(tǒng)記錄所需的所有文件。3 規(guī)劃，制定和管理公司內(nèi)部流程來(lái)監(jiān)測(cè)，預(yù)測(cè)和調(diào)節(jié)研發(fā)和生產(chǎn)過(guò)程。使用適當(dāng)?shù)膶徲?jì)，測(cè)試和統(tǒng)計(jì)過(guò)程控制策略，使所有產(chǎn)品符合質(zhì)量，安全性和有效性的要求。驗(yàn)證對(duì)可能影響質(zhì)量的設(shè)備，工藝，系統(tǒng)和設(shè)施的變化。維護(hù)對(duì)研發(fā)和生產(chǎn)中所有設(shè)備，測(cè)量?jī)x器定期校準(zhǔn)工作。4 管理和產(chǎn)品相關(guān)的認(rèn)證事務(wù)，以確保產(chǎn)品在目標(biāo)市場(chǎng)上推出前完全符合當(dāng)?shù)胤ㄒ?guī)。審查產(chǎn)品開(kāi)發(fā)過(guò)程來(lái)保證設(shè)計(jì)階段就考慮到法規(guī)要求。5 進(jìn)行內(nèi)部審計(jì)程序，以確保產(chǎn)品符合監(jiān)管機(jī)構(gòu)的規(guī)定。制定質(zhì)量方案評(píng)估，鑒定和審核供應(yīng)商，以減少供應(yīng)商來(lái)料質(zhì)量問(wèn)題。6 代表公司進(jìn)行認(rèn)證機(jī)構(gòu)如tuv公司或fda機(jī)構(gòu)對(duì)公司的審計(jì)。7 建立產(chǎn)品生命周期管理從剛開(kāi)始產(chǎn)品概念到產(chǎn)品終結(jié)。8 用技術(shù)，分析和管理的技能來(lái)評(píng)估和解決產(chǎn)品和工藝問(wèn)題。管理關(guān)于產(chǎn)品質(zhì)量的投訴，帶領(lǐng)調(diào)查，進(jìn)行趨勢(shì)分析和采取糾正措施。job responsibilitiesl develops and maintains quality policy through the organization compliant with iso 13485, fda’s qsr, canada’ cmdcas.l educate, train, & advise company professionals to ensure compliance with quality and regulatory requirements.performmarket promotional materials review。audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety. review, approve and maintain all documentation required for system record.l plan, develop and manage program that monitor, predict and regulate the design, manufacturing process using appropriate auditing, testing and statistical process control strategies so that all products meets requirement for quality, safety and efficacy.validate new equipment, processes, systems, and facility changes that impact quality.maintain calibration program for all equipment, measuring devices and plant support system in r&d and manufacturing.l manage regulatory affairs related to the product to ensure full compliance with local regulation before product is introduced in the targeted market. review product development process to assure regulatory requirement is met during design stage.l conduct self-audit program internally to ensure compliance with regulatory agency requirement.develop quality program to evaluate, qualify and audit suppliers to reduce quality issues for incoming material.l represent the company for auditing of certification body and agencies such as tuv or fda.l establish procedure and practice to conduct product lifecycle management from initial concept stage to end of life.l evaluate and solve product and process problems by providing technical, analytical and managerial skills.manage product technical complaints, lead investigations, conduct trend analysis, and drive corrective actions.背景要求本科以上學(xué)歷，受過(guò)醫(yī)療器械、產(chǎn)品知識(shí)等方面的培訓(xùn)；具備五年以上用醫(yī)療器械企業(yè)質(zhì)量體系管理的經(jīng)驗(yàn)。具備三年以上用醫(yī)療器械注冊(cè)、報(bào)批的成功經(jīng)驗(yàn), 以及相關(guān)事故處理報(bào)告, 產(chǎn)品召回經(jīng)驗(yàn)。熟悉iso13485，國(guó)家醫(yī)療器械產(chǎn)品注冊(cè)(sfda, fda, mdd)方面的法律、法規(guī)，安全要求。了解(aami, iec, ul)各項(xiàng)標(biāo)準(zhǔn)，向國(guó)家和藥監(jiān)部門(mén)注冊(cè)申報(bào)的流程和三類醫(yī)療器械注冊(cè)規(guī)定。對(duì)產(chǎn)品研發(fā)流程和生產(chǎn)流程具備很好的了解具有良好的英文聽(tīng)說(shuō)讀寫(xiě)能力；能翻譯外文資料；善于溝通與合作，富有團(tuán)隊(duì)精神。有很強(qiáng)的與各部門(mén)的聯(lián)系及協(xié)作的經(jīng)驗(yàn)。能夠承受較大的工作壓力，具備應(yīng)急事件獨(dú)立處理分析能力qualifications/requirements bachelor’s degree or higher in a technical discipline with good training in medical equipment products. minimum of 5 yearsexperiences in quality system management.minimum of 3 years in managing regulatory affairs of medical device.excellent knowledge of iso13485 system requirement，sfda and fda regulation.understanding of aami, iec, ul standard, fda, sfda application procedure.understand product development process and manufacturing process of medical devices.good with english in speaking, writing and reading perspectives. ability to translate document in english.excellent verbal and written communication and presentation skills, team player, coordinate efforts across departments. work under pressure. the ability to cope with urgency issues independently.