岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

Provide routine Instrument Manufacturing （assembling）service for Biomerieux.

为梅里埃提供日常的仪器生产（组装）服务工作。

Support to set up effective production management procedure and make sure all Biomerieux Global directives, GEP (Good Engineering Practice) and GMP are fully implemented.

协助建立有效的生产管理流程，保证梅里埃总部的指导， GEP 和GMP 规范得到有效贯彻。

Participate in medical device instrument localization and technical transfer and support instrument product registration in China market. 

参与医疗器械仪器本地化技术转移，并支持仪器在中国市场的产品注册。

主要职责 / MAIN ACCOUNTABILITIES

Safety, Health & Environment /安全，卫生和安全

• Learn, master, and follow HSE laws, regulations, requirements and standards of the country, government functional departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.
• 学习、掌握并执行国家、政府职能部门、地方的HSE法律法规要求、标准，履行法规要求的HSE责任和义务。
• Strictly comply with HSE rules and regulations and implement the HSE management requirements of this position. Promise to follow the requirement "do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm". Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely.
• 严格遵守公司HSE规章制度，服从公司的HSE管理，并执行本岗位的HSE管理要求，承诺“不伤害自己、不伤害他人、不被他人伤害，保护他人不受伤害“的四不伤害员工职责。 对被赋予的工作活动做好危害辨识、风险评估、应急预案并确保执行安全操作规范。有责任及时汇报HSE隐患及事故。

Quality and Compliance /质量和法规符合

• Collaborate with site quality to make sure all the operation meets related quality regulation requirements.
• 和本地质量部门合作，确保所有操作满足相关质量法规要求。
• Implement and apply the Biomerieux Quality System.
• 执行并应用梅里埃质量管理系统。

Cost Management /成本控制

• Support line manager to control department expenses within the set year budget.
• 协助直线经理按预算目标控制花费支出。
• Seek continuous improvement opportunities to decrease the operation cost.
• 寻找持续改进方法，降低运行成本。

Routine Operation /日常运营

• Participate in plant Instrument manufacturing activities, including equipment setup, operating, material transfer, workload allocation etc.
• 参与工厂仪器生产活动，包括设备设定、操作、物料转移和人员工作分配等工作。
• As the manufacturing technical expert, responsible for production document updating and related issue handling. This includes creating and updating related SOP, re-qualification support, incident handling and management, change management, deviation investigation and handling.
• 作为制造技术相关专家，负责相关生产文件的更新、生产事件的处理。包括建立并更新相关SOP，再确认支持，突发事件处理与管理，变更管理，偏差调查及处理等。
• Continuously optimize the production layout and production procedure to improve efficiency.
• 持续优化生产区域的布置和生产流程，提高生产效率。
• Leading the production team to complete daily production task per the production plan, and 100% fill-in all kinds of document and paper.
• 带领生产团队按照生产计划完成日常生产任务，并100%按照生产文件填写各种记录。
• ?Other tasks assigned by line manager.
• 直线经理指派的其他任务。

Project Phase / 项目阶段

• Transfer and localize instrument manufacturing related procedures to adapt to China local code and regulations and meet product technical requirements and local standards.
• 转移并本地化仪器生产相关程序以适应中国当地的规范、法规，并符合产品技术要求和本地标准。
• Support instrument type testing and other qualification/verification activities per project needs.
• 基于项目需求，支持仪器的型式检验或其他验证/确认等工作。
• Support site, corporate and local authority quality system inspection activities (e.g., GMP and ISO 13485).
• 支持工厂、集团以及本地监管部门的质量体系审核活动（例如，GMP和ISO 13485）。
• Support instrument product registration in China market. 
• 支持仪器在中国市场的产品注册。

*履行由公司规程规定或由直属上级指派的其他任务。Other tasks as defined in related company procedure, or assigned by the direct supervisor.

备注：公司赋予员工履行上述职责所需的权力。

Notes: Required authority will be provided to implement responsibilities listed above.

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

• Bachelor’s degree (equivalent) or above.
• 本科及以上学历。
• Be familiar with related medical device regulation or codes, such as ISO 9001, ISO 13485 and GMP
• 熟悉ISO 9001, ISO 13485 和GMP等医疗器械相关的法规规范。
• Language skills: Proficient in Listening, Speaking, Reading and Writing of both English & Chinese.
• 语言：英语和中文听、说、读、写熟练。
• Proficient in the use of office software, such as Word and Excel. Familiar with AutoCAD and SAP will be preferred.
• 能熟练操作Word和Excel等办公软件，熟悉AutoCAD 和SAP系统者优先。
• Pharm engineering, bioengineering, mechanical, or electronics related background with no less than 3 years of production experience in IVD (instrument manufacturing and assembly is preferred), or pharma industry.
• 制药工程，生物工程，机械或电子相关背景，具有不少于3年在体外诊断（仪器生产组装优先）或制药工业的生产经验。
• Having instrument transfer project related experience, especially from Europe and/or USA is a plus.
• 具有仪器转移项目相关的经验，尤其是来自于欧美项目的经验优先。
• Good Interpersonal skills and teamwork sprit. 
• 有良好的人际关系能力以及团队合作精神。