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更新于 7月28日

QA質(zhì)量工程師

9000-14000元·14薪
  • 常州新北區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

二類(lèi)醫(yī)療器械過(guò)程質(zhì)量控制ISO13485設(shè)備驗(yàn)證
崗位職責(zé):
1.識(shí)別醫(yī)療器械法規(guī)要求,保證其在研發(fā)及生產(chǎn)過(guò)程的落實(shí);
2.負(fù)責(zé)產(chǎn)品開(kāi)發(fā)質(zhì)量控制文件(進(jìn)料檢驗(yàn)、過(guò)程檢驗(yàn)、成品檢驗(yàn))的編制與檢驗(yàn)工作;
3.負(fù)責(zé)研發(fā)產(chǎn)品的生產(chǎn)過(guò)程驗(yàn)證、設(shè)備驗(yàn)證,對(duì)生產(chǎn)過(guò)程進(jìn)行監(jiān)控,對(duì)變更文件進(jìn)行審核;
4.負(fù)責(zé)主導(dǎo)內(nèi)部質(zhì)量改善,包括6Sigma管理、QC小組和PPAP等為工具的各項(xiàng)改進(jìn)活動(dòng);
5.促進(jìn)產(chǎn)品質(zhì)量提升,負(fù)責(zé)內(nèi)部糾正預(yù)防措施的建立和執(zhí)行。
崗位要求:
1.本科及以上學(xué)歷,生物、機(jī)械或材料學(xué)等相關(guān)專(zhuān)業(yè);
2、2-3年相關(guān)質(zhì)量經(jīng)驗(yàn),英文聽(tīng)說(shuō)讀寫(xiě)良好;
3. 良好的團(tuán)隊(duì)合作和溝通能力;
4.掌握質(zhì)量管理相關(guān)工具,熟悉ISO134855/YY/T0287標(biāo)準(zhǔn),有質(zhì)量改進(jìn)項(xiàng)目管理經(jīng)驗(yàn)。
職位福利:五險(xiǎn)一金、餐補(bǔ)、定期體檢、節(jié)日福利、帶薪年假、周末雙休、14薪

工作地點(diǎn)

新北區(qū)常州樂(lè)奧醫(yī)療科技股份有限公司

職位發(fā)布者

徐女士/招聘經(jīng)理

三日內(nèi)活躍處理簡(jiǎn)歷快
立即溝通
樂(lè)奧醫(yī)療
常州樂(lè)奧醫(yī)療科技有限公司是海外歸國(guó)人員創(chuàng)立的、致力于高端醫(yī)療器械研發(fā)、制造和銷(xiāo)售的高科技中外合資企業(yè)。擁有具備國(guó)際視野和豐富醫(yī)療器械研發(fā)、生產(chǎn)、品質(zhì)和銷(xiāo)售經(jīng)驗(yàn)的優(yōu)秀團(tuán)隊(duì),團(tuán)隊(duì)核心成員擁有多年在海外工作和國(guó)際國(guó)內(nèi)領(lǐng)先企業(yè)從事研發(fā)、銷(xiāo)售的經(jīng)驗(yàn)。Leo Medical Co., Ltd. is a high-tech medical enterprise. We dedicate our work to research, develop, manufacture and market advanced medical devices. We have excellent teams of researchers, engineers, quality assurers and marketers. Many of them have extensive experience in their fields, and have collaborated with experts in various prestigious domestic and international institutions and companies in medical device development field.公司采用領(lǐng)先的生物醫(yī)療技術(shù),服務(wù)于消化系統(tǒng)和血管循環(huán)系統(tǒng)疾病的診斷和治療。公司目前已經(jīng)研發(fā)的產(chǎn)品覆蓋消化和血管介入治療的微創(chuàng)醫(yī)療器械。公司秉承關(guān)注人、依賴(lài)人和服務(wù)人的理念,研發(fā)符合中國(guó)患者特點(diǎn)和中國(guó)醫(yī)生使用習(xí)慣的醫(yī)療器械產(chǎn)品,為醫(yī)生提供方便,為患者減輕病痛。Leo Medical utilizes leading biomedical technologies to develop medical devices for assisting the diagnosis, intervention and treatment of diseases in the digestive system and cardiovascular system. We believe in minimal invasive approach being the most human approach to the patients while not compromising the quality of the procedure. Minimal invasion in medical treatments often allow patients to recover quicker, and doctors to have simplify medical operation. It is a win-win approach for all. We stand by our believes and will continually devote our focus in this area.公司注重安全和質(zhì)量,擁有符合國(guó)家質(zhì)量體系標(biāo)準(zhǔn)的一萬(wàn)級(jí)凈化車(chē)間和高品質(zhì)的檢測(cè)平臺(tái),確保每一件產(chǎn)品的質(zhì)量。公司通過(guò)ISO13485質(zhì)量體系認(rèn)證,合乎國(guó)際質(zhì)量管理體系要求。In addition to features, more importantly, we highly emphasis on safety and quality of our products. Our products are manufactured in 10,000 Class Clean Room(Equivalent to Grand B of ISO standards). We follow repeatable and practical SOPs for product testing online and offline. Leo Medical is accredited with ISO13485:2003 Certificate of Quality Management System and is in fully compliance with The Requirements of International Quality Management System.
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