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Danaher Corporation QA Specialist in Pudong, China

Danaher Company Description
At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.

On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.

Want to know more about our mission and vision? Click on the link:Link of YouTube video

Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.

Radiometer offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives.

Radiometer is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

Join our winning team and Follow us on LinkedIn!

Description

ü 协助质量负责人进行质量管理体系的建立、运行、维护和持续改进。

ü 协助制订质量管理制度,监督制度的执行,并对质量管理制度的执行情况进行检查、纠正和持续改进。

ü 负责收集与医疗器械经营相关的法律、法规等有关规定,实施动态管理;

ü 督促相关部门和岗位人员执行医疗器械的法规规章;

ü 协同相关部门对医疗器械供货者、产品、购货者资质的审核;

ü 负责医疗器械不良事件的收集与报告;

ü 负责医疗器械召回的管理;

ü 组织或者协助开展质量管理培训;

ü 参与公司内部审核;

ü 负责公司经营许可证的办理、更新及变更;

ü 负责不合格医疗器械的确认,对不合格医疗器械的处理过程实施监督;

ü 负责医疗器械质量投诉和质量事故的调查、处理及报告;

ü 组织或协助对第三方物流公司的质量保障能力的审核;

ü 负责医疗器械广告的审批

其他质量经理要求的相关事务

Qualification

· 3 年以上医疗器械生产企业或者经营企业质量保证工作经验(体外诊断类公司经验优先),外资企业医疗器械经营为佳

· 1 年以上质量文件控制和管理的经验

· 1 年以上处理客户投诉经验

· 1 年以上召回管理和不良事件管理经验

· 熟悉有关 CFDA 的 GSP 法规要求,特别是上海市医疗器械经营管理规范实施细则

· 较强的与经销商,公司内部员工以及外部监管机构管理人员的沟通能力

b) 教育背景 Education

· 理工科学位 , 检验学或者生物医学学位尤佳

· 有 ISO13485 内审员证书, ISO 13485 : 2016 内审员资格尤佳

c) 语言 Language

· 流利的英语说写能力

d) 计算机技能 IT

· 熟练掌握现代 IT 工具

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.

Organization: Radiometer
Job Function: Quality and Regulatory Affairs
Primary Location: Asia Pacific-China-China-Shanghai-Pudong
Schedule: Full-time
Req ID: RAD001861

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