Main tasks 工作內容
定期進行品質符合性的抽查
管制項目執行狀況之追蹤及確認，並即時回報管理層
協助有關單位解決品質問題
協助材料、半成品、成品品質檢驗之判定及放行
協助品質事件報告調查與追蹤
管理變更管制，設備驗證，溫度測繪之進度
QA相關要求及規定之執行
拒收、退貨責任歸屬及品質之判定
Detail of the tasks:
每月彙整品保/品管單位之KPI。
安排各項品質計劃如：內部品質稽核、儀器校正、教育訓練、確效、供應商稽核計劃、模擬回收(Mock Recall)進度跟催。
跟催各項異常偏差、稽核缺失、矯正預防之改善進度。
內部品質系統稽核年度總結報告之撰寫。
變更管制之配套措施進度跟催。
負責包裝材料、標示材料、半製品、及產品規格書、檢驗方法之審核。
負責制訂有關儀器、裝置、儀表、記錄器之校正書面作業程序，明確規定校正方法、校正日程表、精確度界限，以及未能符合精確度界限時之限制使用及補救措施。
最終產品判定及放行職責。
產品包裝與進貨檢驗之最後判定或放行。
退回產品篩檢處理後之確認或判定。
負責公司GXP相關文件正本管理。
負責各標準作業程序書之管理、維護、審閱。
負責公司GXP相關文件副本影印、分發與舊版回收。
Must 必備條件
Education 學歷 : 大學以上
Certification 相關證照：ISO13485 & ISO9001 內部稽核員
Experience 相關工作經驗：推行和維護品質管理系統，推行和維護醫療器材QMS
具高度的抗壓性及服務熱忱，做事細心、耐心、負責任。
Maersk is committed to a diverse and inclusive workplace, and we embrace different styles of thinking. Maersk is an equal opportunities employer and welcomes applicants without regard to race, colour, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, pregnancy or parental leave, veteran status, gender identity, genetic information, or any other characteristic protected by applicable law. We will consider qualified applicants with criminal histories in a manner consistent with all legal requirements.
We are happy to support your need for any adjustments during the application and hiring process. If you need special assistance or an accommodation to use our website, apply for a position, or to perform a job, please contact us by emailing [email protected].
Top Skills
What We Do
A.P. Moller - Maersk is an integrated transport and logistics company; going all the way, together, for our customers and society. ALL THE WAY is our commitment to connect the world so that everyone has both the possibility and the ability to trade, grow and thrive.
The company employs roughly 110.000 employees across operations in 130 countries.
