长沙 [切换城市] 长沙招聘长沙生物/制药/医疗器械招聘长沙医疗器械生产/质量管理招聘

Senior Quality Coordinator

贝克曼库尔特商贸(中国)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2017-03-11
  • 工作地点:上海
  • 招聘人数:1人
  • 职位月薪:1-1.5万/月
  • 职位类别:医疗器械生产/质量管理  

职位描述

职位描述:
BASIC PURPOSE OF THIS POSITION:
This will include supports quality system compliance efforts including conducts quality system internal audits and accommodates notify body’s ISO9001 external audit; monitors the effectiveness of corrective and/or preventive action; monitors the trend of customer complaints and coordinates the follow up actions within cross-functional team; coordinates adverse event and product corrective action reporting activities to SFDA.


ESSENTIAL DUTIES AND RESPONSIBILITIES:
The incumbent will also be responsible for, but not limiting to the following duties:

? Support quality manager to develop, maintain and update quality manual, quality plan, quality procedures and instructions
? Conduct internal audits & TPP audits and accommodate external audits; implement and monitor corrective/preventive actions and escalate if necessary
? Coordinate adverse event and product corrective action reporting activities to SFDA
? Handle IPIN/IPCA implementation in China market
? Monitor trend of customer complaints based on the analysis of customer feedback and coordinates the follow up action within cross-functional team
? Work with individual divisions to provide necessary support to dealers and customers for quality system and regulatory compliance

This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.


WORKING RELATIONSHIPS AND CONTACTS:
? External contacts for this position include SFDA officials, dealers, notify body auditors and users/customers
? Internal contacts include all China staff members as well as quality/regulatory staffs from headquarter or other regions



SUPERVISION RECEIVED AND GIVEN:
The incumbent of this position is mostly responsible for his/her own work. Sometimes may need to coach the junior staff within team. Only new work is reviewed before issue, all other work is handled independently, reporting status to quality manager. Some work requires analysis and use of initiative and independent judgment, such as defining audit findings.


ESSENTIAL QUALIFICATIONS:
EDUCATION: Degree holder in science, engineering, quality or relevant discipline
LANGUAGE: Good English and Chinese language skills
COMPUTER: Good command of Microsoft Office: Excel, Word and Powerpoint
EXPERIENCE: Five years working experiences in quality related areas with science, engineering, quality or relevant discipline is preferred.
   

FUNCTIONAL COMPETENCIES:
? Have knowledge in ISO 9001 and experience in quality system auditing is preferred
? Excellent communication skill, maintain frequent contact with internal and external contacts to ensure positive outcomes
? Willing to focus on detailed routine work
? Shows respect for all team members
? Begins learning the company businesses and products and how own function impacts business results
? Some leadership skill in coach junior staff within team
? Learns customer business needs and takes action to meet those needs
? Learns to analyze business processes and customer requirements
? Continuously learns from experiences, particularly non-routine challenges


TRAVEL REQUIREMENTS:
This position may require business traveling in once every month, and during peak season (mid-year and year end) the frequency might be increased.

WORK ENVIRONMENT:
This position functions in a general office environment.

职能类别: 医疗器械生产/质量管理

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公司介绍

贝克曼库尔特有限公司简介:

美国贝克曼库尔特有限公司由贝克曼博士和库尔特兄弟创立,致力于开发和销售仪器、试剂、软件以及能够简化和自动化实验室处理的产品,产品广泛用于世界各地的医院、诊所以及商业实验室。临床诊断解决方案包括:实验室自动化系统、生化分析系统、免疫分析系统、血细胞分析系统、特定蛋白分析系统、尿液分析系统、微生物检测系列、血站血型分析系统。未来的发展中,贝克曼库尔特公司还将以其领先技术、完整的全线产品在医疗设备研发领域持续领跑,继续为全球科学研究的发展作出更杰出的贡献!欲了解更多信息,敬请访问贝克曼库尔特全球网站**********************和中文官方网站*********************

在贝克曼库尔特公司工作的益处:

我们推动行业向前发展
?我们是科学和医疗领域的领先企业。我们的“诊断”产品可帮助医院和实验室尽可能快速和可靠地提供患者诊断结果。我们的“生命科学”产品可帮助科学家在他们的研究中取得突破。
?我们产品的每月使用量达数百万次。
?我们历来重视创新,每年都会推出新产品。
?我们投资于研究和开发,并致力于制造出最优的产品。

我们帮助员工发挥潜力
?我们的文化是坚持持续改进 — 这种文化也深深地影响着我们的员工。
?我们致力于通过激发动力和具有挑战性的工作为员工提供成长机会。
?我们的内部晋升和任职率在业内领先。
?我们利用认可计划 Win as One(共同致胜)确保我们的员工在完成重要任务时得到认可。
?我们全年为员工提供多个发展计划。

我们有独特的工作方式
?虽然我们的工作可能具有挑战性,但员工可以获得经理及其团队的支持。我们共同努力来帮助彼此实现目标。
?Danaher Business System (DBS) 提供了独特的工作环境和获得分析、问题解决技能的机会。
?我们的工作环境和谐友好,并鼓励员工积极提出问题。
?我们坚定推崇多元融合、海纳百川的文化,并邀请员工分享他们的独特经验。

联系方式

  • Email:bccebj@beckman.com
  • 公司地址:长宁区