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* 負責(zé)生產(chǎn)過程的質(zhì)量監(jiān)督,，包含首件檢查、包裝前清場檢查,，成品目視抽檢及批記錄的審核，日志簿審核,，成品放行等,，確保產(chǎn)品質(zhì)量符合產(chǎn)品注冊技術(shù)要求。

Responsible for the quality supervision of the production process, including the first article inspection, pre-production area clearance inspection visual inspection of finished products, batch records review, logbook review and release of the finished goods etc. Ensure that the product quality meets the technical requirements as product registration.

* 負責(zé)缺陷品管理,，質(zhì)量文件歸檔以及程序文件的周期性回顧

Be responsible for the defect sample management, quality documentations’ archiving and periodic review of the procedures.

* 根據(jù)需要支持內(nèi)部和外部的審核活動,。

Supporting internal and external audit activities as necessary.

* 作為質(zhì)量保證主題專家，根據(jù)法規(guī)和公司內(nèi)部質(zhì)量體系要求進行質(zhì)量事件,、原因調(diào)查,、糾正和預(yù)防措施和質(zhì)量變更控制的協(xié)調(diào)和評審。

Serve as QA SME to coordinate and review quality event (QE), cause investigation (CI), CAPA and quality change control per regulations and company internal quality management system requirement.

* 提供質(zhì)量專業(yè)知識,，以符合當(dāng)?shù)蒯t(yī)療器械法規(guī)和相關(guān)標(biāo)準(zhǔn),。

Provide quality expertise to compliant to local medical device regulations and relevance codes.

* 大專及以上學(xué)歷，制藥或醫(yī)療器械科學(xué)/工程或其他相關(guān)專業(yè),，至少3年以上醫(yī)療器械或制藥行業(yè)工作經(jīng)驗,， 至少1年以上質(zhì)量保證經(jīng)驗；或本科及以上學(xué)歷,，制藥或醫(yī)療器械科學(xué)/工程或其他相關(guān)專業(yè),，1年以上醫(yī)療器械或制藥行業(yè)質(zhì)量保證經(jīng)驗。

Colleague degree (equivalent) or above, Pharmaceutical or medical device science/engineering or other related majors , at least 3 years’ experiences in medical device or pharmaceutical industry, at least 1 years’ experience as QA role; or Bachelor degree or above, Pharmaceutical or medical device science/engineering or other related majors, at least 1 years’ experience as QA role in medical device or pharmaceutical industry.

* 熟悉GB/T 42061 (ISO 13485) 及其他質(zhì)量管理體系相關(guān)的法規(guī)及標(biāo)準(zhǔn),，有內(nèi)審員證書為佳,。

Familiar with GB/T 42061 (ISO 13485) and other quality management system related regulations and standards, preferably with an internal auditor certificate.

* 熟悉醫(yī)療器械良好生產(chǎn)規(guī)范，包括但不限于《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范現(xiàn)場檢查指導(dǎo)原則》,、《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》及其相關(guān)附錄,。

Familiar with quality good manufacture practice, including but not limited to "Guiding Principles for On-site Inspection of Good Manufacturing Practice for Medical Devices", "Good Manufacturing Practice for Medical Devices" and their related appendices.

* 良好的英語理解能力。

Understand English well.

* 熟悉精益和六西格瑪質(zhì)量方法論為佳,。

Familiar with Lean and six sigma quality methodology is as better.