南京招聘

Purpose/Objective:

To ensure the company to comply with UL,CCC, CSA, TUV and RoHS regulations and to ensure all the practice and procedure in the plant are able to deliver qualified products to the customers.

Area of Responsibilities:

Quality Management
? Implement the applicable regulations and rules for medical devices and meet their requirements.
? Coordinate with related functional teams for company wide safety requlations compliance action plan.
? Continuously monitor and implement the compliance with safety specification and regulations. Coordinate internally to make sure company all external product audits passed.
? Keep in touched with Leica product ownership company to update all of specifications related to our products.
? Communicate with Safety department from government and get the last request or requirement to ensure the regulation compliance.
? Coperate with R&D department to develop the safety request / specification according to all safety regulations.
? Montor and review all ECR/ DCR/FAI to ensure all of change have followed the safety specifications.
? Perform internal product audit by detail checklist accord to specification to ensure to archive the target.


Qualifications:

? Bachelor degree majoring in Engineering
? Good professional knowledge in optical industry and mechanical industry
? > 8 years of experience in quality control field and > 5 years as supervisor or manager role.
? > 3 years of experience in Medical device manufacturing and familiar with FDA QSR820 & ISO13485 requirements.
? Experience of SFDA regulations are preferred

Personal Skills:

? Good team work spirit and communication skills
? Good English and MS office skill, familiarity with SAP and Lotus preferred.

徕卡显微系统（上海）有限公司成立于1995年，是徕卡仪器（德国）有限公司在中国的全资子公司。位于浦东新区金桥出口加工区，其投资总额为1057万美元，注册资本为680万美元，总面积为10,000平米,员工近500人。2005年徕卡正式加入美国丹纳赫（Danaher）集团，成为丹纳赫生命科学及诊断事业部的一个重要分支。
公司目前主要有两大部门：光学显微系统（Leica Microsystems）和组织病理系统(Leica Biosystems)。
光学显微系统(LMS)包括生物显微镜和医学显微镜，规格从低端到高端，主要应用于教学、医学、科技应用及其它光学系统。作为全球显微制造行业中的佼佼者，公司拥有一流的生产设备和团队，同时其研发力量亦日趋增强。
组织病理系统(LBS)的产品涵盖切片机，脱水机，包埋机，染色机及其他实验室设备，覆盖组织学的每个步骤，并为整个实验室提供高效的工作流程方案。以提供最优质、最全面的病理产品为使命，公司在上海不仅建立了完善的装配生产线，同时也组建了强大的研发团队，从而打造适合中国和世界的一流的病理产品。