1. 組織公司質(zhì)量管理體系的建立、運行、維護,并通過第三方認證;
2. Establish, maintain of the company's quality management system, and pass the third-party certification;負責組織公司質(zhì)量管理體系的內(nèi)部審核、客戶審核、第三方認證審核、藥監(jiān)局產(chǎn)品注冊審核和生產(chǎn)許可證認證審核;
Responsible for organizing the internal audit, customer audit, third-party certification audit, product registration audit of NMPA and production license certification audit;
3. 協(xié)助管理者代表策劃管理評審會議,負責編制管理評審計劃、管理評審會議的輸入和輸出報告;
Assist the management representative to plan the management review meeting, and be responsible for initiating management review plan and manage the input and output reports of the management review meeting;
4. 組織公司質(zhì)量檢驗標準、檢驗流程的制定,并監(jiān)督其運行;
Organize the formulation of the company's quality inspection standards and inspection procedure, and monitoring operation;
5. 組織質(zhì)量管理部管理制度、工作流程的編制、評審和監(jiān)督運行;
Organize the preparation, review and supervision of the quality management system and workflow of the quality management department.
6. 負責組織公司質(zhì)量事故的調(diào)查處理;
Responsible for organizing the investigation and handling of the company's quality accidents.
7. 審核質(zhì)量報告,并作出分析與改善對策;Review the quality report, and make analysis and improvement countermeasures;
8. 負責組織客訴問題的處理、改善和監(jiān)督處理方案和改善方案的執(zhí)行;
Responsible for organizing the handling of customer complaints, improving and supervising the implementation of the disposition plan and the improvement plan;
9. 負責本部門工作計劃的制定、工作總結(jié)和分析;
Responsible for initiating work plan of the quality department, summarize it and analyze it;
10. 負責組織實施本部門的質(zhì)量記錄、數(shù)據(jù)的歸檔工作;
Responsible for organizing and implementing the archiving of quality records and data of the department;
11. 負責下屬工作計劃方案、報告報表、總結(jié)、申請等的審核和工作安排、指導、督促、檢查;
Responsible for management subordinates, guidance, supervision and inspection of work plans , reports, summaries, applications, etc.
12. 負責本部門人力資源的規(guī)劃、評估及任用;
Responsible for developing department, including evaluation, planning, recruiting, appointment.
13. 負責部門間、部門內(nèi)工作溝通、協(xié)調(diào)與配合;
Responsible for internal and external communication, coordination and cooperation.
14. 完成上級安排的其它工作
14.Complete other tasks assigned by director.
任職要求:
1
專業(yè)知識/技術(shù)任職資格
Professional knowledge/technical qualification
精通GMP,ISO13485, MDSAP等質(zhì)量體系
ISO13485內(nèi)審員資質(zhì)
Master GMP, ISO13485, MDSAP and other quality system.
Got ISO13485 certificated as an internal auditor
2
專業(yè)技能
Professional skills
熟悉Word、 Excel、PPT等微軟辦公工具
英文聽說讀寫能力俱佳
Be familiar with Word, Excel, PPT and other Microsoft office software.
Good English listening, speaking, reading and writing skills.
3
能力素質(zhì)
Capability
良好的溝通能力、自我驅(qū)動能力,良好的學習能力,良好的分析和解決問題能力,良好的領導力,抗壓能力強
Good communication skills, self-driven ability, good learning ability, good analytical and problem-solving skills, good leadership, strong ability to work under pressure
4
工作經(jīng)驗/年限
Working experience/years
10年以上工作經(jīng)驗, 6年以上質(zhì)量工作經(jīng)驗
10+ years working experience, 6+ years in quality.
5
其他(學歷等)
Others (education, etc.)
本科以上學歷,生物醫(yī)學工程. 電子機械工程等理工科背景
Bachelor's degree or above in biomedical engineering. Background in science and engineering such as electrical and mechanical engineering