Job ref no.: CT3118200-01#7807

REGULATORY & QUALITY ASSURANCE ENGINEER / SUPERVISOR

Vincent Medical Manufacturing Co., Limited

Benefits
  • 5-day week

工作職責Job responsibility:

(主要工作內容)

  • 網站更新
  • 會員資格維護
  • 內審
  • 不良事件系統維護
  • CE技術文件歸檔
  • 醫療器械產品分類界定
  • 國內註冊產品註冊資料申報
  • 註冊檢驗
  • 臨床試驗
  • NB審核協助
  • 進口註冊產品註冊協助
  • 市場銷售支持
  • 檢驗報告歸檔
  • 上級領導臨時安排的工作

(權限管理)

  • 本職責所擁有的權限
  • 公司官網
  • 網站
  • 不良事件上報系統
  • 分類界定網站
  • 省局行政審批上報系統
  • 臨床機構
  • 代理機構
  • 網站
  • GOA


基本條件Fundamental qualification:

  • 性別:不限; 
  • 習性:無不良喜好.
  • Sex: unlimited; 
  • Habits: no bad taste.



知識水平Knowledge:

  • 本科學歷以上;
  • 英語六級以上。
  • Bachelor degree or above in human resource management major;
  • CET-6 or above.



工作技能Work skills:

  • 獨立領導項目工作的能力;
  • 較強的對外溝通能力;
  • 熟悉公司產品的開發操作流程;
  • 有較強的分析能力、應變能力和組織協調能力;
  • 較強的口頭、書面表達能力;
  • 英語讀、寫能力熟練;
  • 熟練使用Office辦公軟件和AutoCAD軟件。
  • The ability to carry out their work independently;
  • Strong external communication capability;
  • Familiar with development of company’s production progress;
  • Strong analytical skills, adaptability, and organizational coordination;
  • Strong oral and written expression.;
  • Good at English reading and writing;
  • Good skills in Office-software and AutoCAD .

 

工作經驗Work experiences:

  • 4年以上制造型企業工作經驗,有外資企業工作經驗者優先;
  • 有醫療器械註冊經驗者優先;
  • 有GMP,ISO13485質量體系審核經驗,或有內審員資格證者優先。
  • Working experience in manufacturing foreign-invested enterprises for at least 4 year;
  • Medical device registration working experience is preferred;
  • GMP, ISO 13485 quality system or certified quality management system auditor is preferred.


其他要求Other demands:

  • 性格開朗且不失穩重;積極主動;樂觀向上;
  • 具有很強的判斷能力,計劃和執行能力;
  • 嚴謹細致;
  • 充沛的精力。
  • Cheerful personality and does not lose the steady; active, optimistic upward;
  • Has a stronge capacity for diagnosis, planning and implementation capacity;
  • Meticulous and precise;
  • abundant energy.


Candidates with less experience will be considered as Regulatory & Quality Assurance Engineer
Required to station in Dongguan factory and Shenzhen office 5 days per week. 

Attractive remuneration package is provided to the right candidate, including 5 day work, incentive bonus & medical insurance. Interested parties please send your full resume with CURRENT and EXPECTED salary to Apply Now.

All applications applied through our system will be delivered directly to the advertiser and privacy of personal data of the applicant will be ensured with security.

More job information
Job ref no. CT3118200-01#7807
Salary
  • N/A
Job Function
Industry
Employment Term
  • Full-time
Experience
    N/A
Career Level
  • Non-management level
Education
  • N/A