999视频在线免费观看,国产精品一二二区,亚洲国产香蕉视频,中文字幕有码在线视频,亚洲日本另类,中国三级黄色大片,成人中文字幕在线观看

任務/ 職位簡述 Mission/ Position Headline： 負責IVD產品的設計開發(fā)階段的質量管理，跨部門合作推進產品在國內成功注冊與商業(yè)化生產。 包括但不限于：設計控制、工藝驗證、產品放行、上市后監(jiān)管（不良事件、定期風險評價報告等） ，內部和外部審計。 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. 職責領域 Areas of Responsibilties:： - 負責確保IVD產品的設計/生產轉移活動，以滿足國內藥監(jiān)局（NMPA）等設計控制要求。 - 主導風險管理活動，包括推動風險管理檔案的建立、審查和更新。 - 負責原材料、工藝和成品等過程的不合格/偏差/變更/CAPA，并協(xié)調當?shù)刭|量評審委員會的活動。 - 負責為生產、技術、工程等其他跨職能團隊提供質量保證支持，確保各項活動符合質量管理體系要求和國內法規(guī)等要求。 - 負責提供質量法規(guī)或產品知識技能等培訓， 以提高員工的質量法規(guī)意識與技能水平。 - 負責支持產品擬上市與生產許可證的審核準備，以及現(xiàn)場審核和后續(xù)整改的支持工作。 - 負責產品的最終放行。 - 負責產品上市后監(jiān)管活動，包括產品投訴、忠告性通知/產品信息告知、不良事件報告（含定期風險評價報告）、召回等。 - 負責完成上級或公司指派的其他相關項目或任務。 - 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. 經驗Experience ? 從事醫(yī)療器械（IVD）質量工作至少 8年，其中至少 2 年為QA經驗，主要知識包括設計控制、風險管理和變更管理。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. ? 在設計開發(fā)、風險管理和變更管理、以及解決化學發(fā)光試劑產品技術問題等方面，擁有豐富的能力與經驗。Extensive capabilities and experience in design development, risk and change management, and resolving technical issues with chemiluminescent reagent products. ? 具有外部審核準備和接待的成功經驗，并能協(xié)助注冊申報資料的準備。 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，并參加/主導過內審活動。 Have ISO 13485 certification from a third-party organization and has participated/lead internal audit activities. ? 能夠分清多任務項目的輕重緩急，在壓力下可以良好工作。 Ability to prioritize and juggle multiple projects and thrive under pressure. ? 較強的溝通和表達能力。 Strong communication and presentation skills. ? 具備良好的英語口語和書面表達能力。 Good oral and written English is required.