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Sr. Quality Engineer (QMS)_Suzhou in Suzhou, China at Beckman Coulter Diagnostics

Date Posted: 5/11/2019

Job Snapshot

Job Description

Job ID: BEC013997

About Us

Founded in America by Professor Beckman and the Coulter brothers, Beckman Coulter Limited is dedicated to the to the development and sale of instruments, reagents, software and products that simplify and automate laboratory processing that are widely used in hospitals, clinics, and commercial laboratories worldwide. Clinical diagnostic tools implemented within company products include: laboratory automation systems, biochemical analytical systems, immunoassay systems, hematology systems, protein chemistry systems, urinalysis systems, microbiological detection and analysis systems, and blood bank analytical systems. In future developments, Beckman Coulter will continue to lead in the field of medical equipment research and development with cutting-edge technology and complete product lines, and continue to make outstanding contributions to the development of global scientific research! For more information, please visit www.beckmancoulter.com.


Description

1、  负责质量手册、程序文件等体系文件的编制、修订、宣贯等工作。
2、 协助建立、维护和持续改进公司质量管理体系,保证质量体系有效运行;
3、 负责推进医疗器械GMP条款在公司各业务部门的落实、改进工作。
4、 负责做好公司内审及管理评审工作,和外部审核前的准备工作;和监督检查中及内审与外审中不符合项的追踪与验证工作。
5、 负责公司各项业务工作流程的梳理、优化和改进工作
6、 负责质量体系相关的培训工作,提升公司员工的质量意识。
7、 完成上级安排的其他工作。

Job Requirements



Qualifications

1、 大学本科及以上学历,生物技术、医学检验、机械电子等相关专业。
2、 至少从事医疗器械行业质量管理体系工作5年以上,曾在IVD企业质量部工作的候选人优先考虑。
3、 熟悉质量管理体系和医疗器械法规要求等专业知识i.e.FDA QSR820,IVDD/MDD,NMPA(CFDA)等法规。
4、接受过ISO1348:2016 内审员培训,并有多次组织或参加内审的实际工作经验。
5、曾经有过组织和协调外部审核工作的经验,比如FDA药监局等现场审核。
6、良好的英语沟通(英文报告和流利口语)能力。
7、良好的组织沟通,以及跨部门合作能力。



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.