长沙招聘

职位描述：
BASIC ROLES OF THIS POSITION:
This position will include but not limit to the following roles: Document management aligned with global and local quality system; Promotional and advertisement materials review/approvals for both MD/IVD and non-IVD products; advert events (AE), customer feedback (CF), field action (FA) and recall tracking process and communications; Advertisement submissions and AE/FA reports to CFDA and follow-ups; Internal and external auditing on commercialization organizations, distributors and suppliers.

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

? Support quality supervisor/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 CFDA
? Monitor trend of customer complaints based on the analysis of customer feedback and coordinates the follow up action within cross-functional team
? Review and approval advertisements/promotional materials including preparing package submissions and communications with CFDA.
? Work with individual divisions to provide necessary support to dealers and customers for quality system and regulatory compliance

WORKING RELATIONSHIPS AND CONTACTS:
? External contacts for this position include CFDA 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 responsible for his/her own work. Only new work is reviewed before issue, all other work is handled independently, reporting status to quality supervisor/manager. Some work requires analysis and use of initiative and independent judgment, but most assignments are specific and well defined.

ESSENTIAL QUALIFICATIONS:
EDUCATION: Degree holder in science, engineering, quality or relevant discipline
LANGUAGE: Good English and Chinese language skills
COMPUTER: Good MS office computer skill (Excel, Word, PowerPoint)
EXPERIENCE: Two 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
? 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 a fewness situation.

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

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。