Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following).
主要职责和最终结果:(主要职责包括但不限于以下内容)
Responsible to drive the project team for ensuring all of the project requirements and/or objectives are correctly gathered, understood and properly translated for execution (for example product and tooling drawing, quality acceptance criteria, HSF requirements etc.)负责推动项目团队确保所有项目要求和/或目标都得到正确收集、理解和适当转化,以便执行(例如产品和工具图纸、质量验收标准、HSF 要求等)。
Collaborate with customer (internal or external) from requirements gathering through product acceptance/ approval into mass production and throughout product life time.与客户(内部或外部)合作,从需求收集到产品验收/批准,再到批量生产和整个产品生命周期。
Align the project team to customer needs by establishing milestones, goals, and objectives based on input from all functional areas and stakeholders within the project.根据项目内所有职能领域和利益相关者的意见,制定里程碑、目标和目的,使项目团队与客户需求保持一致。
Perform regular reviews of project risks and risk mitigation plans and status within the assigned Workcell and Business Unit.在指定的工作小组和业务部门内定期审查项目风险和风险缓解计划及状况。
Provide guidance and motivation to project teams to successfully achieve project goal and corporate initiatives.为项目团队提供指导和激励,以成功实现项目目标和企业倡议。
Serve as interface with customers, vendors, stakeholders and project sponsor(s).充当与客户、供应商、利益相关者和项目发起人的接口。
Manage development of project plans with focus on achievement of project goals and corporate initiatives, including project specific Key Performance Indicators (KPI’s) or metrics and manage regular review with the project team, based on these KPI’s.管理项目计划的制定,重点是实现项目目标和企业倡议,包括项目特定的关键绩效指标(KPI)或衡量标准,并根据这些关键绩效指标与项目团队一起管理定期审查。
Management of resource capacity and time tracking allocated to the project.管理分配给项目的资源能力和时间跟踪。
Accountable for overall project success - including cost, schedule, quality and scope management.对项目的整体成功负责,包括成本、进度、质量和范围管理。
Monitor project status, issues and implemented solutions as well as evaluations and assessments of the results监测项目状态、问题和已实施的解决方案,以及对结果的评估和评价
Drive continuous improvement through trend reporting analysis and metrics management通过趋势报告分析和指标管理推动持续改进
Demonstrate a commitment to customer service; anticipate, meet and exceed expectations by solving problems quickly and effectively, making customer issues a priority.展示对客户服务的承诺;通过快速有效地解决问题,将客户问题作为优先事项,预测、满足并超越客户的期望。
Job Qualifications: The minimum education and experience required to perform this job competently.
任职要求:(胜任该岗位的最低学历和经验要求等)
Knowledge requirements 所需知识:
Demonstrated Leadership and Management capabilities.领导和管理能力突出。
Project Management Professional (PMP) or equivalent certification desirable.最好获得项目管理专业人员 (PMP) 或同等认证。
Knowledge of organization’s operating policies and procedures required需要了解组织的运营政策和程序
Knowledge of organization’s culture and guiding principles.了解组织文化和指导原则。
Previous experience in manufacturing environment: Engineering, Injection molding, Quality, Planning, Materials, etc. ,曾在制造环境中工作过: 工程、注塑、质量、规划、材料等方面的经验。
Prior experience in customer interface具有与客户沟通的经验
Consultative skills (ability to understand true customer needs)咨询技能(了解客户真正需求的能力)
Good communications skills良好的沟通技巧
Distinctive problem-solving leader解决问题的杰出领导者
Should have the following personal characteristics: strong leader, professional, hard-charging, detail-oriented, reliable, calm under fire, creative, with a can-do attitude.应具备以下个人特点:领导能力强、专业、勤奋、注重细节、可靠、临危不乱、有创造力、态度积极。
Medical/Healthcare manufacturing background experience as required要求具有医疗/保健制造背景经验
Proficient in English writing, speaking and reading.精通英语写作、口语和阅读。
Education & Experience Requirements 教育和经验要求
Bachelor’s degree required or equivalent education and training要求获得学士学位或者同等学历的教育和培训
PMP certified professional is desirable最好是获得 PMP 认证的专业人员
Minimum 5 years work-related experience required in a supervisory/management role, project management experience or related discipline or an equivalent combination of education, training and/or experience至少 5 年的监督/管理经验、项目管理经验或相关学科的工作经验,或同等的教育、培训和/或经验组合
Be professional in related manufacturing technologies and multi-cavity injection tooling(over 16 cavities).具备相关制造技术,多型腔注塑模具方面的专业知识。
Familiar with the ISO Quality Management System and regulation requirements, such as: ISO13485, EUMDR,FDA 21CFR Part 11& Part 820 and China Medical Device Manufacturing Quality Management Regulation (China FDA Notification No.64 of 2014),can build up quality awareness and quality improvements.熟悉ISO质量管理和法规要求,比如:ISO 13485,EUMDR ,FDA 21CFR,中国医疗器械生产质量管理规范(中国食品药品监督管理局公告2014年第64号)和相关附录,并能够树立质量意识和质量改进。
Be familiar with ISO and GMP requirements. To provide coaching and technical guidance to the project team members.熟悉 ISO 和 GMP 要求。为项目团队成员提供辅导和技术指导。
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