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【崗位看重點(diǎn)】
1. 二類(lèi)及以上外科醫(yī)療器械5年經(jīng)驗(yàn)（偏外資經(jīng)驗(yàn)）
2. 帶領(lǐng)團(tuán)隊(duì)1-2戰(zhàn)略升級(jí)，ISO13485質(zhì)量管理體系經(jīng)驗(yàn)+良率提升底層邏輯設(shè)計(jì)及推動(dòng)
【崗位總述】
確保企業(yè)質(zhì)量管理體系有效運(yùn)行，保障產(chǎn)品全生命周期符合法規(guī)、標(biāo)準(zhǔn)及客戶(hù)要求，通過(guò)持續(xù)改進(jìn)提升產(chǎn)品質(zhì)量和企業(yè)合規(guī)能力，最終實(shí)現(xiàn)對(duì)患者安全的保障和市場(chǎng)競(jìng)爭(zhēng)力的增強(qiáng)。
To ensure the effective operation of the enterprise's quality management system, guarantee that the entire product life cycle complies with regulations, standards, and customer requirements. Improve product quality and the enterprise's compliance capabilities through continuous improvement, and ultimately achieve the protection of patient safety and the enhancement of market competitiveness.
【崗位職責(zé)】
1. 負(fù)責(zé)質(zhì)量部管理體系的建立，運(yùn)行，維護(hù)，組織內(nèi)部審核完成內(nèi)審報(bào)告及相關(guān)記錄，并監(jiān)督檢查改進(jìn)和落實(shí)情況；
Responsible for establishing, operating, and maintaining the quality department's management system; organizing internal audits, completing internal audit reports, and related records; and supervising the implementation of corrective actions and follow-up.
2. 負(fù)責(zé)組織質(zhì)量工程師對(duì)供應(yīng)商審核及評(píng)審設(shè)計(jì)開(kāi)發(fā)各階段相關(guān)文件，監(jiān)督設(shè)計(jì)開(kāi)發(fā)過(guò)程符合性；
Responsible for organizing quality engineers to conduct supplier audits and review design and development documents at various stages, ensuring compliance with design and development processes.
3. 負(fù)責(zé)醫(yī)療器械產(chǎn)品質(zhì)量管理，依據(jù)質(zhì)量控制程序要求，正確識(shí)別各項(xiàng)質(zhì)量管控點(diǎn)，組織制定管理規(guī)程，指導(dǎo)、監(jiān)督執(zhí)行；
Responsible for quality management of medical devices, identifying key quality control points based on quality control procedures, developing management regulations, and guiding and supervising their implementation.
4. 負(fù)責(zé)組織專(zhuān)人收集與醫(yī)療器械生產(chǎn)、經(jīng)營(yíng)相關(guān)的國(guó)內(nèi)外法規(guī)標(biāo)準(zhǔn)等有關(guān)規(guī)定、實(shí)施動(dòng)態(tài)管理；
Responsible for organizing the collection of domestic and international regulations and standards related to medical device production and distribution, and managing their implementation dynamically.
5. 加強(qiáng)生產(chǎn)過(guò)程中的質(zhì)量控制，組織質(zhì)量工程師對(duì)質(zhì)量管理中出現(xiàn)的質(zhì)量問(wèn)題進(jìn)行分析、判斷和處理，組織實(shí)施不合格品處理，執(zhí)行標(biāo)識(shí)、記錄、隔離、臨時(shí)措施和/或糾正預(yù)防措施、關(guān)閉；
Strengthen quality control during production processes, organize quality engineers to analyze, judge, and handle quality issues, implement nonconforming product management (including identification, record-keeping, isolation, temporary measures, and corrective/preventive actions), and ensure closure of issues.
6. 負(fù)責(zé)組織對(duì)生產(chǎn)批記錄的審核及成品放行；
Responsible for organizing the review of production batch records and release of finished products.
7. 組織編制、審核質(zhì)量管理體系相關(guān)的程序文件、管理制度及SOP等，確保質(zhì)量管理工作的規(guī)范化和標(biāo)準(zhǔn)化，如依據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》、《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》、ISO13485及國(guó)外相關(guān)體系法規(guī)等制定完善的質(zhì)量管理體系文件，并監(jiān)督各部門(mén)嚴(yán)格執(zhí)行；配合技術(shù)部涉及的驗(yàn)證工作，組織專(zhuān)人校準(zhǔn)相關(guān)設(shè)施設(shè)備量具及儀表等；
Organize the development and review of quality management system-related procedures, management systems, and SOPs to ensure standardized and regulated quality management. This includes establishing a comprehensive quality management system in accordance with regulations such as the "Regulations on the Supervision and Administration of Medical Devices," "Good Manufacturing Practices for Medical Device Production," ISO 13485, and other relevant international standards. Supervise strict implementation by all departments and support validation activities related to the technical department, including calibration of facilities, equipment, gauges, and instruments.
8. 組織質(zhì)量工程師及時(shí)收集、分析和處理客戶(hù)投訴，組織相關(guān)部門(mén)進(jìn)行原因分析，制定并實(shí)施糾正預(yù)防措施，防止問(wèn)題再次發(fā)生；
Organize quality engineers to collect, analyze, and handle customer complaints, conduct root cause analysis with relevant departments, and implement corrective and preventive actions to prevent recurrence.
9. 根據(jù)公司的發(fā)展戰(zhàn)略和市場(chǎng)需求，組織制定質(zhì)量目標(biāo)和質(zhì)量計(jì)劃，并將其分解到各個(gè)部門(mén)和崗位，確保質(zhì)量目標(biāo)的有效落實(shí)和達(dá)成；
Based on the company's development strategy and market demands, formulate quality objectives and plans, break them down to various departments and positions, and ensure their effective implementation and achievement.
10. 參與新產(chǎn)品研發(fā)項(xiàng)目的質(zhì)量策劃，從質(zhì)量角度對(duì)產(chǎn)品設(shè)計(jì)、工藝選擇、原材料采購(gòu)等環(huán)節(jié)提出專(zhuān)業(yè)意見(jiàn)和建議，確保新產(chǎn)品在研發(fā)階段就符合質(zhì)量要求；
Participate in the quality planning of new product development projects, providing professional opinions and suggestions on product design, process selection, and raw material procurement from a quality perspective to ensure compliance with quality requirements during the R&D phase.
11. 負(fù)責(zé)組織相關(guān)人員實(shí)施公司內(nèi)部審核和管理評(píng)審；
Responsible for organizing internal audits and management reviews within the company.
12. 負(fù)責(zé)迎接外部審核機(jī)構(gòu)包括各認(rèn)證機(jī)構(gòu)及客戶(hù)的審核和現(xiàn)場(chǎng)檢查工作，如醫(yī)療器械質(zhì)量管理體系的認(rèn)證審核，積極配合審核工作，及時(shí)提供相關(guān)資料和信息，確保企業(yè)順利通過(guò)審核和認(rèn)證;
Responsible for coordinating external audits and on-site inspections by certification bodies and customers, such as certification audits of the medical device quality management system. Actively cooperate with audit activities, provide relevant documentation and information in a timely manner, and ensure the company passes audits and certifications smoothly.
13. 負(fù)責(zé)部門(mén)的日常管理工作，指導(dǎo)、培訓(xùn)、評(píng)估和激勵(lì)部門(mén)員工，提高部門(mén)整體工作效率和氛圍；
Responsible for the daily management of the department, including guiding, training, evaluating, and motivating department staff to improve overall departmental efficiency and morale.
14. 完成上級(jí)領(lǐng)導(dǎo)安排的其它工作。
Complete other tasks assigned by senior management.
【任職要求】
1. 有8年及以上醫(yī)療器械生產(chǎn)企業(yè)行業(yè)質(zhì)量管理工作經(jīng)驗(yàn)
Have more than 8 years of work experience in quality management within the medical device manufacturing enterprise industry.
2. 統(tǒng)招本科及以上學(xué)歷，醫(yī)學(xué)、藥學(xué)、生物、醫(yī)療器械、機(jī)械電子、質(zhì)量管理等相關(guān)專(zhuān)業(yè)。
University bachelor's degree or above, with majors in medicine, biology, medical devices, mechanical electronics, quality management, or related fields.