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質(zhì)量工程師 5-9.9千/月/月

微仙醫(yī)療科技(杭州)有限公司

杭州

  • 工作年限
  • 學(xué)歷要求本科
  • 招聘人數(shù)
  • 發(fā)布日期03-01 發(fā)布
  • 語(yǔ)言要求
職位信息

職位名稱: 質(zhì)量工程師

類別名稱:

職位描述:
職位描述:1.Prepare quality specifications and receiving specifications起草制定產(chǎn)品檢驗(yàn)規(guī)范(包括來(lái)料和成品)2.Coordinates and assists with first article inspections負(fù)責(zé)安排首件確認(rèn)3.Coordinates and supports product testing (e.g. biocompatibility testing)配合支持其他產(chǎn)品相關(guān)測(cè)試(如:生物相容性檢測(cè))4.Conducts test method validations負(fù)責(zé)檢測(cè)方法確認(rèn)、驗(yàn)證。5.Works with manufacturing engineers to review product /process changes and resolve product quality issues.與生產(chǎn)工程師合作, 完成產(chǎn)品或工藝過(guò)程變更的評(píng)審執(zhí)行,處理日常發(fā)生的產(chǎn)品的質(zhì)量問(wèn)題。6.Works with suppliers to maintain high quality levels of incoming production materials. 及時(shí)與供應(yīng)商溝通來(lái)料的質(zhì)量問(wèn)題, 確保問(wèn)題得到及時(shí)解決。7.Conducts quality audits of suppliers. 負(fù)責(zé)供應(yīng)商審審核和評(píng)估。8.Coordinates implementation of new equipment used for inspection by preparing equipment specifications and by participating in installation qualifications and operational qualifications 負(fù)責(zé)檢驗(yàn)設(shè)備的標(biāo)準(zhǔn)制定,安裝和運(yùn)行確認(rèn),以及員工使用培訓(xùn)。9.Supports the manufacturing of new products 配合新產(chǎn)品轉(zhuǎn)移。10.Develop test protocols and reports (design verification, design validation, process qualification and process validation) 針對(duì)設(shè)計(jì)確認(rèn)、過(guò)程確認(rèn)等,負(fù)責(zé)編寫(xiě)制定確認(rèn)方案和執(zhí)行。11.Develop the PFMEA. 負(fù)責(zé)制定維護(hù)PFMEA12.Supports various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing and quality metrics data analysis 針對(duì)質(zhì)量報(bào)告(如CAPA,NCR,供應(yīng)商質(zhì)量報(bào)告,設(shè)備校準(zhǔn)報(bào)告,內(nèi)審等等)進(jìn)行數(shù)據(jù)分析 。13.Perform training & certification to QC on Inspection.負(fù)責(zé)QC檢驗(yàn)方面的培訓(xùn)和考核。14.Conduct Sterilization process validation (including EtO & E-beam sterilization). 負(fù)責(zé)執(zhí)行滅菌過(guò)程確認(rèn)(包括環(huán)氧乙烷滅菌和電子束滅菌)15.Review the DHR. 對(duì)產(chǎn)品歷史記錄進(jìn)行評(píng)審。16.Duties as assigned 完成上級(jí)安排的其他工作。
任職要求:
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