【崗位看重點】
1. 二類及以上外科醫療器械5年經驗（偏外資經驗）
2. 帶領團隊1-2戰略升級，ISO13485質量管理體系經驗+良率提升底層邏輯設計及推動
【崗位總述】
確保企業質量管理體系有效運行，保障產品全生命周期符合法規、標準及客戶要求，通過持續改進提升產品質量和企業合規能力，最終實現對患者安全的保障和市場競爭力的增強。
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】
1. 負責質量部管理體系的建立，運行，維護，組織內部審核完成內審報告及相關記錄，并監督檢查改進和落實情況；
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. 負責組織質量工程師對供應商審核及評審設計開發各階段相關文件，監督設計開發過程符合性；
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. 負責醫療器械產品質量管理，依據質量控制程序要求，正確識別各項質量管控點，組織制定管理規程，指導、監督執行；
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. 負責組織專人收集與醫療器械生產、經營相關的國內外法規標準等有關規定、實施動態管理；
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. 加強生產過程中的質量控制，組織質量工程師對質量管理中出現的質量問題進行分析、判斷和處理，組織實施不合格品處理，執行標識、記錄、隔離、臨時措施和/或糾正預防措施、關閉；
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. 負責組織對生產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、審核質量管理體系相關的程序文件、管理制度及SOP等，確保質量管理工作的規范化和標準化，如依據《醫療器械監督管理條例》、《醫療器械生產質量管理規范》、ISO13485及國外相關體系法規等制定完善的質量管理體系文件，并監督各部門嚴格執行；配合技術部涉及的驗證工作，組織專人校準相關設施設備量具及儀表等；
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. 組織質量工程師及時收集、分析和處理客戶投訴，組織相關部門進行原因分析，制定并實施糾正預防措施，防止問題再次發生；
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. 根據公司的發展戰略和市場需求，組織制定質量目標和質量計劃，并將其分解到各個部門和崗位，確保質量目標的有效落實和達成；
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. 參與新產品研發項目的質量策劃，從質量角度對產品設計、工藝選擇、原材料采購等環節提出專業意見和建議，確保新產品在研發階段就符合質量要求；
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. 負責組織相關人員實施公司內部審核和管理評審；
Responsible for organizing internal audits and management reviews within the company.
12. 負責迎接外部審核機構包括各認證機構及客戶的審核和現場檢查工作，如醫療器械質量管理體系的認證審核，積極配合審核工作，及時提供相關資料和信息，確保企業順利通過審核和認證;
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. 負責部門的日常管理工作，指導、培訓、評估和激勵部門員工，提高部門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. 完成上級領導安排的其它工作。
Complete other tasks assigned by senior management.
【任職要求】
1. 有8年及以上醫療器械生產企業行業質量管理工作經驗
Have more than 8 years of work experience in quality management within the medical device manufacturing enterprise industry.
2. 統招本科及以上學歷，醫學、藥學、生物、醫療器械、機械電子、質量管理等相關專業。
University bachelor's degree or above, with majors in medicine, biology, medical devices, mechanical electronics, quality management, or related fields.