BD (Becton, Dickinson and Company) 品管工程师(质量体系合规)_质量部_苏州_苏州一厂 in Suzhou Plant 1, China

Job Description Summary

按照医疗器械质量体系要求规范执行质量数据分析,工程变更指令管理,质量文件维护管理, 批记录审核,质量管理工具应用。

Based on QMS requirement to execute control for QDA, ECO, document maintenance, DHR review and quality management tool application.

作为QA的协调者在TrackWise系统中全面负责客户投诉的处理和跟踪。

In full responsibility of QA coordinator role for handling and tracking customer complaint with Trackwise system.

Job Description

1) 质量管理体系数据分析过程(QDA)要求的数据收集和分析,用于QNs, RTFT, CPM和质量业绩趋势的分析。

Quality data collection & analysis for QDA process of QMS to address QNs, RTFT, CPM, and trend analysis to quality performance.

2) 在BD文件更改过程(ECR/O)中作为工厂变更控制的协调者

Plant Change Control coordinator with ECR/O process of BD

3) 工厂在ECC6.0系统中控制文件的关键使用者。

Document control with ECC 6.0 as one of plant key user

4) 指定医疗器械批记录(DHR)的审核

DHR review for the assigned product group

5) 在TrackWise 系统中对顾客投诉进行操作,协调工厂顾客投诉调查过程的实施及调查结果的报告。

Customer complaint handling with TrackWise system for coordinating plant investigation process executed and investigation result reported

6) 市场部质量团队(上海质量部RCC/客户投诉中心DCHU,研发,销售)和顾客在产品质量问题的处理保持沟通渠道。

Communication channel maintained to business QA team (RCC/DCHU, R&D, market) and customers for product quality issues

7) 质量管理体系QMS或总部要求的其他的顾客相关程序的实施。

Other customer experience program implemented as QMS or cooperate required.

8) 上级分配的其他工作,包括部门目标,法规要求,亚太/大中华区GA/GC的要求。

Superior assigned other work set up to department goals, regulatory requirements, GA/GC requirements.

Primary Work Location

CHN Suzhou Plant 1

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.