医科达北研（北京）医疗器械有限公司

Job Description

• Develop User & Technical Service manuals as part of new product development.
在新产品开发过程中编制用户及技术维修手册
• Maintain and update existing User & Technical Service manuals.
维护并更新已有用户及技术维修手册
• Collect and process relevant information from medical and engineering specialists.
从医学和工程专家处收集并处理相关信息
• Working as an individual as well as part of a team.
能够独立工作，同时具有较强的团队合作精神
• Provide input and shape documentation strategy, e.g. emedia, epublishing and other information delivery methods.
提供输入和形成文件的策略，如：电子媒体，电子出版和其他信息传递方法
• Adhere to processes, company templates and standards.
坚持流程，公司模板和标准
• Plan, manage and report document progress.
计划、管理和汇报文档进展
• Produce documentation plans, review forms and device master files ensuring compliance with audit criteria.
制定文档计划，评估表以及保有主文档确保与稽核标准相符
• Assemble documents into PDF format; working with suppliers for quality checking and preparing for delivery.
将文档转换成PDF格式；与供应商协作进行质量检查及发运准备

Responsibilities

• To work within existing documentation processes and to company standards.
根据已有的文档流程和公司标准工作
• To proactively obtain and collate design information as source material for the creation of required documentation.
预先收集、比较设计信息，据此产生所需文档
• To work within cross-functional design project teams, defining documentation and information requirements.
在交叉功能的设计团队内工作，定义所需文档和信息
• To work with Quality Assurance, Regulatory Affairs and Safety departments to make sure documents are compliant.
与质量保证、法规事务和安全部门协作，确保文档合乎规范
• To participate in project and other meetings as required making sure that the needs of documentation activities are considered and distribute relevant information throughout the department and to customers.
根据需要参加项目和其他会议，确保考虑产生文档所需信息并将相关信息传达至部门和客户
• To plan and manage documentation creation progress, to report any risks or slippage to project team / functional management.
计划和管理文档创建流程，向项目团队/主管经理报告文档创建的风险或质量下降
• To proactively ensure that document review process and schedules are met.
主动确保符合文档评估流程和进度
• That First-of-Kind meets necessary quality standards.
符合必须的质量标准
Relevant knowledge, skills and competencies.

• Recognised scientific or engineering qualification.
认可的科学或工程资质
• Good understanding of the English language.
良好的英语水平
• Documented business/industrial experience.
商务/工业领域工作经验
• Excellent communication skills, both verbal and written.
优良的口头和书面沟通技巧
• Demonstrate initiative.
有上进心
• Ability to plan and control project progress.
能够计划和控制项目进程
• Strong interpersonal skills.
优良的人际技巧
• Prepared to learn new skills.
乐于学习新的知识/技巧
• Prepared to undertake international travel.
可以根据需要出差