国产中文无码av每日更新在线观看, 亚洲天堂中文字幕一区二区三区免费, 国产口爆吞精在线观视频-黄色国产, 92福利-国内精品久久久久久99,亚洲成AV人A片不卡无码,浪潮AV无码专区,老熟女败火白浆,中文字幕日产av,色情日本免费看大片

愛德華（上海）醫(yī)療用品有限公司
崗位名稱：高級(jí)質(zhì)量專員
工作地點(diǎn)：上海辦公室（徐家匯）或外高橋倉(cāng)庫(kù)
JD：
1.
DC(SLC) Quality Management
-
Implement and maintain Product Inspection Process and Product
Release Process, including Imported Finished Goods, Over-Labeled Products, and
Returned Products;
-
Implement and track Quality Hold(Global & local) in 3PL;
-
Drive improvement for 3PL Quality Management System, implement and
maintain Quality Agreements;
-
Drive and execute rework activities;
-
Initiate and track internal complaints resulting from labeling
non-compliance;
-
Perform first article inspection (FAI) for product distributed in
greater China region
2.
Supplier Management
-
Maintain existing supplier and support in new supplier
qualification9APM);
-
Work with cross-functional team on NCR, CAPA, and Product Risk
Assessment (PRA) Process, including the required document preparation in a
timely manner. Follow up CAPA and SCAR action plan;
-
Provide Quality Training to supplier;
-
Implement Supplier Control Process
3.
Post Market Quality Assurance
-
Complaint report translation
-
Product Complaint Handling Process, includes receiving and
reporting complaints to CH Center, following up Complaint Investigation, and preparing
Customer Response Letter in Local Language.
-
MDR process: Assess reportable complaints and report ADE to
Competency Authority according to Local Regulation.
-
Field Corrective Action Process, includes operations in JDE
system. Act as Local FCA Coordinator.
4.
Respond to internal customers data requests and external/internal
auditors or inspections to Edwards Quality Management System;
5.
Develop, lead, and/or contribute to the implementation of proposed
modifications to resolve open issues, as a part of cross-functional / project
team, to bring the process knowledge;
6.
Other incidental duties: Implement continuous improvement program
or project assigned by manager.
Requirements:
1.
Education Level：Bachelor;
2.
Experience：5 Years(Experience in a quality and/or
manufacturing environment in the medical device industry);
3.
Strong written and verbal communication skills in English;
4.
Full knowledge of medical or pharmaceutical regulations as
relating to documentation (e.g. Good Documentation Practices);
5.
Full understanding of medical devices regulations (e.g., ISO13485,
Local Regulatory Requirements);
Adhere to all company
rules and requirements (e.g., pandemic protocols, Environmental Health &
Safety rules) and take adequate control measures in preventing injuries to
themselves and others as well as to the protection of environment and
prevention of pollution under their span of influence/control.