职位描述
职位职责 (简要说明)
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? Responsible for new product quality plan and make sure compliance of medical device regulation and quality system
? Responsible for legacy product maintenance and continuous improvement.
? Responsible for customer complain investigation, risk analysis, corrective and preventive action, effectiveness, handle customer complaint in time, continuous improve the customer satisfactions,
? Responsible for organize related department on non-conforming product review and disposition.
? Drive and implement process improvements to achieve First Time Quality (e.g. Error proofing, Measuring Automation activities, Yield improvements)
? 负责新产品质量管理策划, 确保其医疗器械法规和体系的符合性;
? 负责老产品的维护和持续改进；
? 负责客诉的调查、风险分析、纠正和预防措施及其有效性, 及时处理客诉，持续提升客户满意度；
? 负责组织相关部门对不合格品评审和处置。
? 驱动和实施过程改进，达成FTQ（First Time Quality）（如防错、自动测量、提高产量）。
主要工作内容/职责（列举清单）
Responsibility （List）
? Responsible for new product quality planning, ensure compliance with medical regulation and system requirement.
? Responsible for legacy product maintenance and continuous improvement.
? Responsible for customer compliant investigation, risk analysis, corrective and preventive action and effectiveness, deal with customer complaint in time, continuous improve customer satisfactions.
? Lead Material Review Board (MRB) to dispose nonconforming material, identify the root cause and initiate corrective/preventive actions to eliminate defects. (e.g. Flow chart, 5 Why, Fish bone)
? Responsible of effective implementation of corrective and preventive action, advisory notice and adverse event report and continuous improvement.
? Accomplish responsible work per priority in a high quality and high efficiency manner, even under multi-task pre-condition.
? Continuous improve product quality and process.
? Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment. (e.g. Gage design, GR&R )
? Responsible for inspection method training, and standardize inspection method, come out with work instruction.
? Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s, Risk Reduction)
? Define process, product and test method validation requirements, preparation and approval of validation protocols and reports. (e.g. EIQ/EOQ/POQ/PPQ)
? Prepare weekly report\monthly report from raw material to finished goods full process quality per company and department target and come out with corrective preventive action, in order to meet target.
? Attend to maintain and monitor quality system running and organization, internal quality audit.
? Accomplish task assigned by leader.
? 负责新产品质量管理策划, 确保其医疗器械法规和体系的符合性;
? 负责老产品的维护和持续改进；
? 负责客诉的调查、风险分析、纠正和预防措施及其有效性, 及时处理客诉，持续提升客户满意度；
? 负责主导MRB物料评审委员会对不合格品评审和处置，识别根本原因，启动纠正/预防措施消除缺陷，如：流程图、5-为什么、鱼骨图。
? 负责纠正预防措施有效实施、忠告性通知和不良事件报告及持续改进工作；
? 负责在多任务的前提下，按照优先级，高质量和高效率地完成本职工作；
? 持续改善产品质量和流程；
? 负责满足程序的检验、试验方法的设计和开发，评估检验、试验方法或产品/过程/测试设备的精度要求、可靠性，如：检具设计、MSA)；
? 负责培训检验员检验方法，并标准化检验方法，形成作业指导书。
? 确保过程所有变量和影响因素被充分定义，确保所有的过程失效模式被充分识别和解决，如：使用DOE研究，FMEA，降低风险：
? 确定过程、产品和试验方法验证要求，准备和批准验证方案和报告(e.g. EIQ/EOQ/POQ/PPQ)。
? 根据公司整体质量目标和部门目标，针对原材料至最终产品全过程质量的分析周报、月报，并形成必要的纠正预防措施，达成目标；
? 参与维护、监督质量体系的运行、组织和内部质量审核工作；
? 完成上级委派的其它任务。
任职资格 Qualification
知识/教育程度 Knowledge / Education level
? Bachelor Degree，major in mechanical or engineering
? College degree, if with equivalent experience
? 本科学历，机械、工程专业，
? 大专学历，若有相当资深的工作经验也可
经验/能力要求 Experience/Ability Requirement
? More than 2-3 years working experience in this position, working experience in medical device industry is preferred.
? Proficiency in AutoCAD, MS-office, statistical software, Minitab;
? Familiar with APQP, PPAP, MSA, quality control methods, statistical process control, 6-, Sigma
? ISO9001:2000, TS16949 internal auditor experience, ISO13485 internal auditor experience is preferred;
? With the quality system and CAPA system working experience.
? With ability to work independently and capable of working with a cross functional team.
? With multi-task experience
? With good skill of listen, written and oral English;
? 2-3 年以上本岗位工作经验，有医疗器械行业工作经验为佳；
? 熟练使用AutoCAD，MS-office，统计软件Minitab；
? 熟悉APQP, PPAP, MSA, 质量控制方法, 统计过程控制，6- Sigma,
? ISO9001：2000，TS16949 内审员经验，有ISO13485内审员经验优先；
? 具备系统的质量体系和CAPA的工作经验
? 具备独立工作能力并有和跨功能团队工作的能力
? 具备多任务的工作经验
? 良好的英语听说读写能力;
