主题:【原创】布鲁克(北京)科技有限公司刚刚发布了Quality Specialist 质量专员职位,坐标,速来围观!

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职位名称:Quality Specialist 质量专员
职位描述/要求:职责描述:
Ensure compliant and effective QMS’s are maintained in scope; support standardization of QMS processes.
Drive process change management.
Ensure document control and ensure training profiles are assigned and enforced and training administration is established.
Ensure quality requirements are effective in all processes.
Support external and internal audit readiness and provides support during external and internal audits.
Actively participate in quality initiatives as a cross-functional contributor.
Maintain the QMS while driving QMS transformation locally in support of strategic initiatives.
Demonstrate operational excellence and ensure quality in all deliverables.
Assist in document generation and registration of in vitro diagnostic medical devices where required.

任职要求:
Bachelor’s degree in Engineering, Science or equivalent plus a minimum of 2 years of quality management related experience in the medical device or in vitro diagnostic medical device industry.
Good understanding of appropriate Chinese medical device regulations (NMPA), requirements and standards. Experience of ISO 13485 and ISO 14971
Experience with other Asian medical device regulations and compliance such as ASEAN CTD, MDSAP, Japanese MHLW Ordinance 169 would be an added plus.
Experience in registration of in vitro diagnostic medical devices would be advantageous, but not essential.
Excellent computer skills and the ability to transcribe inspection/audit proceedings in real time.
Project management and process/organizational change management experience.
Demonstrated flexibility in prioritizing and completing tasks and communicating potential conflicts.
Solid organizational and interpersonal skills plus strong communication.
Ability to analyze information and come to conclusions based on presented data.
Fluent in Chinese, with good level of English.
公司介绍: 布鲁克(北京)科技有限公司总部位于美国,是在纳斯达克上市的世界著名的高科技分析仪器跨国企业,以生产质谱仪、核磁共振谱仪、傅立叶红外/拉曼光谱仪,近红外、傅立叶电子顺磁共振波谱仪、原子力显微镜、光学轮廓仪、摩擦磨损测试设备等高水平、高精度分析仪器享誉全球科技界。
布鲁克公司创立于 50 多年前,自创立伊始,公司始终秉持一条理念:为每个分析任务提供最佳技术解决方案。如今,公司遍布全球的 6000多名...查看全部
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