Quality Specialist 质量专员职位描述/要求：
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.
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