质量工程师/quality/QA/QE-欧美知名医疗品牌

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质量工程师/quality/QA/QE-欧美知名医疗品牌 0.8-1.2万/月/月

上海帝博企业管理咨询有限公司

上海

大专
04-05 发布

职位信息

职位名称：质量工程师/quality/QA/QE-欧美知名医疗品牌

类别名称：

职位描述：

职位描述：Responsibilities:Lead/involved in 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.Ensure that the root cause of issues, their corrective and preventive action processes within the facilities are effectively identified, the CAPAs are well implemented and verified.Lead the resolution of issues within the contract manufacturers / suppliers and supply chains, with usage of data, quality tools, statistical applications, PDCA and etc. to make decisions.Work with Quality Management to further develop, optimize and improve processes to be compliant to to ISO 13485 and US Quality Systems Requirements at local Cardinal site and each contract manufacturing site and that the system complies with all necessary regulatory requirements.Help develop, coordinate and execute quality objectives and key performance metrics in collaboration with the contract manufacturers/ suppliers and internal functional teams and these are met to deliver applicable product performance and minimize the cost of quality.Key team player to identify the improvement opportunity on both product and process. And lead the improvement project by using lean/six sigma knowledge.Requirements:Possess a Diploma / University Degree in Science/Engineering discipline.Minimum 3 years relevant experience in medical device 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. Internal/External auditbackground is necessary.Resourceful, organized and able to work independently in a fast paced environment.Able and willing to travel extensively 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.Knowledge in injection molding and its validation is a plus.

任职要求：

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