Senior QA Engineer_Suzhou in Suzhou, China at Beckman Coulter Diagnostics

Date Posted: 6/11/2019

Job Snapshot

Job Description

Job ID: BEC014186

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

本岗位工作偏重于“过程质量、系统质量”的“确认、符合、改进”等相关质量活动。 工作范围包含过程管理、系统管理等与质量系统相关过程的符合和改进活动,从 顾客的角度来管理质量。包含:
• 过程质量保证,产品实现(批记录、检验记录、新原料、新产品的审核)
• 过程质量保证,失效管理(不合格品、不符合项、顾客投诉的调查)
• 过程质量保证,有效管理(验证、校验、变更、新产品设计转移和各种改进项目的跟踪)
• 系统质量保证,系统发展(人员资格、培训要求的确立和跟踪)
主要职责:
1. 质量管理系统的日常运作管理,如文件记录、验证记录的规范和控制等;
2. 产品主生产记录(如批记录、质量计划等)的日常分发、审核和归档;
3. 产品合格报告的审核、产品放行(状态变更)、COA的签署和发布;
4. 过程问题的调查,验证和校验要求,变更的确认和实施跟踪;
5. 在新产品设计转移过程中承担主要角色确保产品合规顺利转移实施;
6. 在验证与变更过程中承担主要角色确保过程符合程序文件与相关法规要求。
7. 系统的收集相关信息去考虑问题的因素,抓住问题中复杂和可识别的关系;
8. 运用部门的(功能性区域)的观点去做出决定或者实施新的计划或变更;
9. 寻求外部反馈以提高工作技能,寻求改进的措施以增加顾客满意度;
10. 在多重工作中关注于关键目标,克服潜在的障碍达到目标;
11. 识别并关注于关键的可交付的或者优先完成的任务;
12. 能够完成常规的和非常规的项目目标,并且处理复杂的问题;
13. 在复杂的项目中或者小的团队中作为项目或团队领导为组织服务;
14. 能够积极有效的和外部沟通以保证得到正确的结果;
15. 运用统计学的方法识别部门内可能会影响其他部门满足顾客需求的障碍;
16. 参与外部的研讨会、访问顾客及其他公司以持续不断的发展;
17. 在其他部门交叉工作以打破部门的分界来改进过程;
18. 理解顾客的需要和期望,站在顾客的角度提出建议和改进;
19. 完成QA主管安排的其他工作。


Job Requirements



Qualifications

理工类本科八年以上(或研究生五年以上)工作经验;
体外诊断行业从事相同工作岗位本科三年以上; 具有免疫产品技术背景;
较好的管理技能,临时性的质量保证主管代理;
熟悉ISO13485,GMP,当地法规和行业技术要求;
熟悉产品相关的法律法规(如IVD-GMP等)和内审员资格;
掌握质量管理的七大手法、SPC、FMEA等质量工具;
具有汇报、分析、解决和发现潜在问题的能力;
在质量活动中有较好的组织能力,并有较好的管理能力和沟通技巧;
熟练的管理时间技巧,掌握轻重缓急,人员管理和协调能力;
熟练的英语沟通(英文报告和流利口语)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.