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Engineer - Manufacturing Support 制造支持工程师

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Engineer - Manufacturing Support 制造支持工程师

澳科利耳医疗器械(北京)有限公司

Engineer - Manufacturing Support 制造支持工程师

Skills

Compliance

2 months ago

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Important information


Contract type:

Permanent

Location:

Chengdu, Sichuan, China

Work mode:

Onsite

Published on:

3 September 2026

What they need


该职位来源于猎聘 Accountabilities 主要职责 Accountability 1: Manufacturing support 职责 1:制造支持 Analyze manufacturing rejects as required to reclaim where possible, identify, and rectify root causes of rejects. 根据需要对生产中的不合格品进行分析,在可能的情况下进行回收,找出导致产生不合格品的根本原因并加以纠正。 Provide fast response or solutions to day-to-day specific manufacturing problems raised in the Fast Response meetings.

针对快速响应会议上提出的日常生产具体问题,提供快速响应解决方案。

Provide equipment and product process related training to team member and ensure the effectiveness of the training. 为团队成员提供设备和产品工艺相关的培训,并确保培训的有效性。 Responsible for supporting Manufacturing to increase manufacturing capacity and yield. 负责支持制造部产能和良率提升。 Responsible for Validation & Verification planning, execution and reporting. 负责验证和确认计划的执行和报告。 Ensure NCRs, Concessions and Change Notice are processed in a timely manner. 确保NCR、让步和变更记录得到及时处理。 Take responsibility of translations and reviewing Work Instructions/Procedures when QMS and DMRs upgrades are required. 根据需要,在 QMS 和 DMR升级时负责翻译及审核工作。 Backup other Manufacturing Support Engineers when resources are constrained or skill overlap is required. 当考虑到存在资源受限或技能重叠的情况时,增援其他制造支持团队。 Accountability 2: Project Work 职责 2:项目工作 Execute projects to maximise manufacturing efficiencies on existing manufacturing processes, including the selection of appropriate equipment. 执行项目以最大限度地提高现有生产流程的生产效率,包括选择适用的设备。 Take responsibility of NPI projects, eg. New product, new process, new equipment. 负责 NPI 项目实施,例如新产品、新工艺、新设备。 Execute projects to review and improve manufacturing “indirect” processes. Such as paperwork, bar-coding etc. 执行项目以评审和改进生产“间接”流程,如文书工作、条形码相关工作等。 Accountability 3: Point of contact for other departments 职责 3:作为面向其它部门的对接人 Monitor progress of improvement plans and provide feedback to interested parties. 监测改进计划的实施进度,并向相关方提供反馈。 Accountability 4: Compliance to regulations 职责 4:合规性 Ensure that Good Manufacturing Practice (GMP) is followed. 确保遵循质量管理规范 (GMP) 开展工作。 Ensure all documentation meets the requirements of the QMS. 确保所有文件都符合质量管理体系的要求。 Responsible for rectifying issues identified in the audited areas under one's responsibility, and supporting other areas as required.负责审核后的所负责区域问题发现项整改,并根据需要支持其他区域。 Team Role (Individual contributor) 团队角色(个人贡献者):

Follow relevant quality procedures in order to deliver high quality products and services. Identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.g. audit) when appropriately trained and being competent. 遵循相关质量规程,交付优质产品和服务。识别改进机会,支持开展持续改进工作。在接受了相应工作培训,足以胜任的情况下,担负额外的质量职责(例如审核)。 Contribute ideas on systems and process methods to improve deliverables. 针对系统和流程方法献计献策,以提高可交付成果的质量。 Work safely, complying with all safety procedures, rules and instructions; and reporting workplace hazards, incidents or injuries to manager. 工作中确保安全,遵守所有安全规程、规则和指示说明;发现工作场所存在安全隐患或发生事故、人员受伤,及时报告管理人员。                         Key Incumbent requirements任职要求: Bachelor or above in Engineering (Mechanical or Microelectronics or Biomedical or Automation). 本科学历及以上。工程领域(机械、微电子、生物医学或自动化相关专业毕业。 Ability to use English as a daily working language (verbal, writing and reading). 能够将英语作为日常工作语言(口语,并具有良好的写作和阅读技能)。 Strong logical thinking and self-learning ability, good team player, and strong communication skill. 逻辑思维强,具有自主学习能力,有较强团队合作能力,沟通能力强。 1 years+ experience in a similar manufacturing support role within a highly regulated industry 1 年以上在受到高度监管的行业中担任类似生产支持职务的经验 Experience in working within a Quality Management System (QMS) 具有在质量管理体系内工作的经验 Proven competencies in problem solving, design, manufacturing / business process development and personal influence 在解决问题、设计、制造/业务流程制定和提高个人影响力方面具有能力且经过了证明

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