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崗位職責:

1體系建立與維護

System establishment and maintenance

組織建立和健全公司ISO13485、ISO9001、醫(yī)療器械生產(chǎn)質量管理規(guī)范、經(jīng)營質量管理規(guī)范等管理體系，確保有效運行

Organize the establishment and improvement of the company’s management systems such as ISO13485, ISO9001, medical device production quality management specifications, and operational quality management specifications to ensure effective operation

組織修訂、完善質量管理體系文件；

Organize the revision and improvement of quality management system documents;

推動和優(yōu)化工作質量體系，確保流程滿足各國質量法規(guī)監(jiān)管要求，推動流程效率不斷提升。

Promote and optimize the work quality system, ensure that the process meets the regulatory requirements of various countries

quality regulations, and promote the continuous improvement of process efficiency.

2指導和監(jiān)督體系運作

Guidance and supervision system operation

依據(jù)質量體系文件要求，進行質量體系策劃，并監(jiān)控策劃實施情況；

Carry out quality system planning according to the requirements of quality system documents, and monitor the implementation of the planning;

組織編制質量管理體系內審和管理評審實施計劃，并主導完成內審和管理評審，輸出內審、管理評審報告；

Organize the preparation of the implementation plan for the internal audit and management review of the quality management system, and lead the completion of the internal audit and management review, and output the internal audit and management review reports;

根據(jù)第二、三方審核計劃，策劃審核準備及審核安排，指導各部門對審核發(fā)現(xiàn)的不符合項整改及效果驗證，收集和匯總不符合項整改資料；

According to the second and third party audit plans, plan audit preparation and audit arrangements, guide various departments to rectify and verify the non-conformities found in the audit, collect and summarize non-conformance rectification data;

參與各部門質量提升及提案改善項目、改善效果評審。

Participate in the quality improvement and proposal improvement projects of various departments, and the improvement effect review.

3糾正預防措施推進

Corrective and preventive measures advance

及時收集、統(tǒng)計、分析體系管理相關數(shù)據(jù)結果，并負責驗證各項糾正、預防措施及改進方案的有效性；

Collect, count and analyze system management related data results in time, and be responsible for verifying the effectiveness of various corrective and preventive measures and improvement plans;

負責質量問題的跟蹤處理。

Responsible for the tracking and handling of the quality issues.

4體系培訓

System training

負責公司員工管理體系知識的培訓；

Responsible for the training of company employee management system knowledge;

組織質量體系文件培訓，并指導各部門建立和完善質量管理體系。

Organize quality system document training, and guide various departments to establish and improve the quality management system.

5體系檔案管理

System file management

體系管理相關文件、記錄的存檔管理。

Archive management of relevant documents and records of system management.

任職要求:

專業(yè)資格/職業(yè)資格

Professional qualifications

具備相關的專業(yè)知識背景

Have relevant professional knowledge background

工作經(jīng)驗

Work Experience

3年以上醫(yī)療器械行業(yè)相關經(jīng)驗

More than 3 years of relevant experience in the medical device industry

知識技能

Knowledge skills

熟悉或了解質量體系標準要求：ISO13485、FDA CFR820、醫(yī)療器械生產(chǎn)質量管理規(guī)范等，內審員優(yōu)先；

Familiar with or understand the quality system standard requirements: ISO13485, FDA CFR820, medical device production quality management specifications, etc., internal auditors are preferred;

掌握數(shù)據(jù)分析的方法和工具，掌握質量管理常用的工具和方法；具有處理質量問題的良好的思路和邏輯，以及跨部門溝通和協(xié)調的能力；

Master the methods and tools of data analysis, master the tools and methods commonly used in quality management; have good ideas and logic for handling quality issues, and the ability to communicate and coordinate across departments;

熟練使用辦公軟件；

Proficiency in using office software;

英語溝通流利者可優(yōu)先考慮

Fluent English communication is preferred

能力素質

Competence

具備高度責任心，工作態(tài)度嚴謹、細致；

Have a high sense of responsibility, rigorous and meticulous working attitude;

思維清晰有條理，良好的表達能力，能夠合理安排時間獨立完成工作；能承受較大工作壓力。

Clear and organized thinking, good expression skills, able to arrange time to complete work independently; able to withstand greater work pressure.