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任務(wù)/ 職位簡(jiǎn)述 Mission/ Position Headline： 負(fù)責(zé)IVD產(chǎn)品的設(shè)計(jì)開(kāi)發(fā)階段的質(zhì)量管理，跨部門合作推進(jìn)產(chǎn)品在國(guó)內(nèi)成功注冊(cè)與商業(yè)化生產(chǎn)。 包括但不限于：設(shè)計(jì)控制、工藝驗(yàn)證、產(chǎn)品放行、上市后監(jiān)管（不良事件、定期風(fēng)險(xiǎn)評(píng)價(jià)報(bào)告等） ，內(nèi)部和外部審計(jì)。 Responsible for quality management of IVD products during the design and development phase, and cross-departmental cooperation to promote the successful registration and commercialization of products in China. Including but not limited to: design control, process validation, product release, post-marketing surveillance (adverse events, periodic risk evaluation reports etc.), internal and external audits. 職責(zé)領(lǐng)域 Areas of Responsibilties:： - 負(fù)責(zé)確保IVD產(chǎn)品的設(shè)計(jì)/生產(chǎn)轉(zhuǎn)移活動(dòng)，以滿足國(guó)內(nèi)藥監(jiān)局（NMPA）等設(shè)計(jì)控制要求。 - 主導(dǎo)風(fēng)險(xiǎn)管理活動(dòng)，包括推動(dòng)風(fēng)險(xiǎn)管理檔案的建立、審查和更新。 - 負(fù)責(zé)原材料、工藝和成品等過(guò)程的不合格/偏差/變更/CAPA，并協(xié)調(diào)當(dāng)?shù)刭|(zhì)量評(píng)審委員會(huì)的活動(dòng)。 - 負(fù)責(zé)為生產(chǎn)、技術(shù)、工程等其他跨職能團(tuán)隊(duì)提供質(zhì)量保證支持，確保各項(xiàng)活動(dòng)符合質(zhì)量管理體系要求和國(guó)內(nèi)法規(guī)等要求。 - 負(fù)責(zé)提供質(zhì)量法規(guī)或產(chǎn)品知識(shí)技能等培訓(xùn)， 以提高員工的質(zhì)量法規(guī)意識(shí)與技能水平。 - 負(fù)責(zé)支持產(chǎn)品擬上市與生產(chǎn)許可證的審核準(zhǔn)備，以及現(xiàn)場(chǎng)審核和后續(xù)整改的支持工作。 - 負(fù)責(zé)產(chǎn)品的最終放行。 - 負(fù)責(zé)產(chǎn)品上市后監(jiān)管活動(dòng)，包括產(chǎn)品投訴、忠告性通知/產(chǎn)品信息告知、不良事件報(bào)告（含定期風(fēng)險(xiǎn)評(píng)價(jià)報(bào)告）、召回等。 - 負(fù)責(zé)完成上級(jí)或公司指派的其他相關(guān)項(xiàng)目或任務(wù)。 - Responsible for ensuring design/manufacturing transfer activities for IVD products to meet design control requirements such as the National Medical Products Agency (NMPA). - Lead risk management activities including driving the creation, review and update of risk management files. - Responsible for nonconformities/deviations/changes/ CAPAs for processes such as raw materials, processes and finished products, and coordinates the activities of the local Quality Review Board. - Responsible for providing quality assurance support to other cross-functional teams such as production, technology, engineering, etc. to ensure that activities are in compliance with QMS requirements and domestic regulations, etc. - Responsible for providing training on quality regulations or product knowledge and skills to improve employees' awareness of quality regulations and skills. - Responsible for supporting the preparation of products to be marketed and production license audits, as well as on-site audits and subsequent corrective actions. - Responsible for final product release. - Responsible for post-market regulatory activities, including product complaints, advisory notices/product information notification, adverse event reports (including periodic risk assessment reports), recalls, etc. - Responsible for completing other related projects or tasks assigned by supervisor or the company. 經(jīng)驗(yàn)Experience ? 從事醫(yī)療器械（IVD）質(zhì)量工作至少 8年，其中至少 2 年為QA經(jīng)驗(yàn)，主要知識(shí)包括設(shè)計(jì)控制、風(fēng)險(xiǎn)管理和變更管理。Minimum of 8 years in medical device (IVD) quality with at least 2 years of QA experience with key knowledge in design control, risk management and change management. ? 在設(shè)計(jì)開(kāi)發(fā)、風(fēng)險(xiǎn)管理和變更管理、以及解決化學(xué)發(fā)光試劑產(chǎn)品技術(shù)問(wèn)題等方面，擁有豐富的能力與經(jīng)驗(yàn)。Extensive capabilities and experience in design development, risk and change management, and resolving technical issues with chemiluminescent reagent products. ? 具有外部審核準(zhǔn)備和接待的成功經(jīng)驗(yàn)，并能協(xié)助注冊(cè)申報(bào)資料的準(zhǔn)備。 Successful experience in external audit preparation and reception and able to assist in the preparation of registration filings. ? 具有第三方組織頒發(fā)的ISO13485證書(shū)，并參加/主導(dǎo)過(guò)內(nèi)審活動(dòng)。 Have ISO 13485 certification from a third-party organization and has participated/lead internal audit activities. ? 能夠分清多任務(wù)項(xiàng)目的輕重緩急，在壓力下可以良好工作。 Ability to prioritize and juggle multiple projects and thrive under pressure. ? 較強(qiáng)的溝通和表達(dá)能力。 Strong communication and presentation skills. ? 具備良好的英語(yǔ)口語(yǔ)和書(shū)面表達(dá)能力。 Good oral and written English is required.