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高级工程师,质量保证
1.5-2.5万·13薪
人 · 本科 · 5年及以上工作经验 · 性别不限2025/01/21发布
五险一金补充医疗保险带薪年假带薪病假年终奖金定期体检免费班车

浦东新区

低价好房出租>>

直观复星总部及产业化基地

公司信息
直观复星医疗器械技术(上海)有限公司

合资/500-1000人

该公司所有职位
职位描述
Primary Function of Position:
Provides subject matter expertise to distribution quality compliance to GSP and labeling regulation requirements, including ERP/IT system, 3PL warehouse daily operation quality, NC handling, and facilitate on the Chinese label and IFU etc.

Roles and Responsibilities:
This position has responsibility and authority for:
1.Work as quality contact window with 3PL warehouse, supervise the warehouse quality related activities, including CN labeling, inbound, inventory management, outbound, etc.
2.Be responsible for the quality management at 3PL warehouse, Coordinate with local stakeholders on SOP/WI creation/maintenance, conduct training to warehouse staff, perform routine audit, handle abnormal event, monitor the nonconformance products control etc.
3.Process owner of *** Launch Approval, NC Control and other related GSP SOP. Conduct GSP and related SOP training to staff.
4.Responsible for GSP regulation compliance, GSP license maintenance and NMPA audit.
5.Leading 3PL and distributor annual audit. Support internal and external audit.
6.Responsible for CN labeling (including IFU) and process improvement.
7.Support business per commercial QA side.

Skill/Job Requirements:
1.Bachelor’s degree or above.
2.More than 5 years experience in the relevant role of MNC.
3.Good knowledge of GSP and related regulations.
4.Be proficient in written and spoken English is solid required.
5.Good communication skill, project experience will be a plus.
6.Strong analytical skills and ability to solve the problem.
7.Proficiency in Microsoft office software office.

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