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From Stryker’s original posting
Work Flexibility: Onsite KEY RESPONSIBILITIES / DUTIES主要职责: • Lead, oversee, coordinate and facilitate the activities in a production area or manufacturing cell ensuring safety, quality, and compliance while achieving production goals, efficiency and yield targets and cost objectives.在达成产量目标,效率,良率目标及成本管控的基础上领导,管理,协调及促进生产区域内确保安全,品质及合规的生产。 • Full compliance and enforcement of all Safety, GMP, Regulatory, Product Quality, Company Policies and Environmental requirements.确保遵守和执行所有安全、GMP、监管、产品质量、公司政策、政府和环境的要求,以及法律法规的要求。 • Stop further processing in the event of encountering non-conforming product condition.终止会产生不合格产品的生产流程。 • Train and/or coordinate the training and required qualifications of personnel within assigned area.对于制定区域需要授权的员工培训或协调安排培训。 • Ensure product is manufactured to the most current/validated method/process and specification and DHR for every lot is correctly filled in per GMP & QS requirements.确保产品参照最新的/验证并生效的方法/流程生产,并确保每个产品的DHR按照GMP及QS的要求正确的填写。 • Develop, coordinate and/or implement root cause problem solving, preventive and corrective actions.协调及/或执行问题解决,预防和纠正措施。 • Ensure equipment, tools, fixtures, gages and measuring devices are properly used, maintained and…
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