職位描述
職位描述：
KEY RESPONSIBILITIES（主要職責）
1. Participate non-conformity investigation, corrective action implementation, action tracking and close related CAPA;參與不合格品的調查、措施實施、跟蹤及關閉有關CAPA；
2. Manage and planning for incoming and out-going inspections;管理安排，計劃進料及成品的檢驗。
3. Establish testing procedures and finish test method validation. Review test data and report;制定檢驗方法并驗證，審核檢驗數據和報告；
4. Participate on quality system continuous improvement; 參與工廠質量體系的持續改善；
5. Keep good communication with supplier, and resolve raw material quality issue and keep continuous improvement; 通過供應商進行良好溝通，解決進料質量問題和持續改進
6. Make sure all of the test assignment can completed in a timely manner, and establish training program for inspectors;確保各項檢驗任務準確及時完成。培訓檢驗員。
7. Participate in the internal and external audit; 參與公司的內部及外部審核。
8. Participate in analysis and verification of complaint samples. 參與投訴樣品的分析與驗證。
9. Responsible for managing and maintaining the retained samples and quality record.負責留樣產品與質量記錄的管理與維護。
10. Responsible for team's development plan;團隊的發展計劃
11. Assigned by QA manager, on behalf of QA manager to handle whole department working; 經QA經理授權，代理QA經理負責部門工作
SKILLS AND ABILITIES（技能）
1. Bachelor degree or above;本科或以上學歷畢業；
2. At least 8 years quality experience;相關工作經驗8年以上；
3. Familiar with China related regulation of medical device;熟悉國家有關的醫療器械法規；
4. Familiar with ISO9001/ISO13485 quality management system, and familiar with GMP requirement; 熟悉ISO9001/ISO13485質量管理體系，熟悉GMP要求；
5. Familiar with the lab requirement and related SOP of medical device and pharm industry; 熟悉醫療器械/醫藥行業的實驗室要求及SOP；
6. Validation practice in medical device or pharmaceutical company is preferred; 具有醫療器械或制藥公司相關驗證經驗的優先；
7. Familiar with the statistical analysis of 6-sigma. Capable to perform data analysis and SPC quality control. 具有6-sigma統計學相關知識，有數據分析和SPC管控知識和經驗；
8. Good at planning and execution ability; 良好的計劃和實施能力；
9. Good communication skill, learning ability and good adaptability;良好的溝通技巧、學習能力及適應能力；
10. Familiar with Microsoft office software; 電腦辦公軟件應用熟練；
11. Fluent English skills both oral and writing; 流利的英語聽說讀寫能力;
企業簡介
Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.
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