Quality Engineer

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Quality Engineer 0.1-1千/月/月

康德乐医疗设备咨询（上海）有限公司

上海

03-01 发布

职位信息

职位名称： Quality Engineer

类别名称：

职位描述：

职位描述：Responsibilities:?Support process validation, supplier assessment/qualification and achieve quality goals set for contract manufacturing and suppliers.?Facilitate to establish Statistical and Process Control techniques/quality control plans and other QC tools at contract manufacturer/suppler sites to ensure process control and performance meets Cardinal's expectations.?Lead/facilitate that the root cause analysis, the corrective and preventive action are effectively identified, and the CAPAs are well implemented and verified.?Participate or lead in the resolution of quality related issues within the contract manufacturers / suppliers and internal team, with usage of data, quality tools, statistical applications, PDCA and etc. to make decisions.?Perform surveillance audit and Maintain of quality system processes to ensure it compliant to to ISO 13485 and US Quality Systems regulatory requirements.?Monitor key quality performance metrics and improve or close the gap in collaboration with the contract manufacturers/ suppliers and internal functional teams and these are aimed to deliver applicable product quality performance and minimize the cost of quality.?Involve and support the improvement project by using lean/six sigma knowledge.Requirement:?Possess a Diploma / University Degree in Science/Engineering discipline.?Minimum 2 years relevant experience in quality operations or quality engineering.Familiarity in quality control and quality assurance activities related to contract manufacturers / suppliers / plants.?Direct quality system/process audit experience.?Good time management for multi-tasks and able to work independently in a fast paced environment.?Able and willing to travel (average 30%) within China.?Good communication (both Chinese and English is required) andinterpersonal skills.?Good knowledgeable in ISO13485 or FDA GMP/QSR 820 or equivalent quality system.?Experience in sterile products is a plus.?Ability in delivering expected results.?Good Team player.?Knowledge on Lean/6 Sigma methodology.

任职要求：

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