角色概述Role Overview
该职位负责执行质量保证(QA)和质量控制(QC)相关活动，持续监督和改进相关流程，确保质量符合外部和内部要求（国内和国内法规、标准、指南等）。
This position is responsible for carrying out activities related to quality assurance and quality control, continuously monitoring and improving relevant processes, and ensuring that quality meets external and internal requirements (domestic and international regulations, standards, guidelines, etc.).

职责Duties and Responsibilities
•参与联诺特(LINET)太仓本地制造项目的质量管理活动的导入和运行，支持本地项目合规、高效落地。
Participate in the introduction and operation of quality management activities for LINET Taicang local manufacturing in China, supporting the compliance and efficient implementation of localization projects.
•与本地团队和受委托生产企业合作，参与质量管理体系的持续维护。
Collaborate with the local team and the entrusted production site to participate in the continuous maintenance of the quality management system.
•参与委托生产的管理，对受委托生产企业进行定期、不定期的现场检查，促进保持良好的生产规范。
Participate in the management of entrusting production, conduct regular and irregular on-site inspections of entrusted production sites, promote the maintenance of good manufacturing practices.
•导入并执行物料和产品的质量控制活动，确保物料符合生产要求、产品符合放行要求。
Introduce and implement quality control activities for materials and products, ensuring that materials meet production requirements and products meet release criteria.
•监督委托生产企业的关键检验项目，确保检验结果真实、可靠。
Supervise the critical inspection items of the entrusted production site to ensure the authenticity and reliability of the inspection results.
•执行必要的数据分析，发现相关过程中的改进机会点，为持续改进提供支持。
Perform necessary data analysis to identify improvement opportunities in relevant processes and provide support for continuous improvement.
•被授权作为放行审核人，审核批记录，以放行原材料、半成品和成品。协助产品上市放行审核。
Authorized as release reviewer, review batch related documents to release raw material, semi-finished goods and finished products. Assist review on product release to market.
•参与验证管理、供应商管理、偏差处理、不合格处理、变更控制、CAPA处理、客户投诉和不良事件处理等质量保证活动。
Participate in quality assurance activities such as validation management, supplier management, deviation handling, nonconformity handling, change control, CAPA handling, customer complaints, and adverse event handling.
•支持管理评审相关活动，与相关职能准备相关数据并分析，并为评审过程相关过程提供改进建议。
Support management review related activities, prepare relevant data and conduct analysis in collaboration with relevant functions, and provide improvement suggestions for processes related to the review process.
•支持内部和外部审核。
Support internal and external audit program.
•处理上级交办的项目。
Handle projects as tasked by supervisor.

以下是在产品转移项目阶段确定的一些优先事项：
Below are some priorities identified during the Product Transfer project phase:
•在产品转移阶段对质量管理体系文件进行差距分析，确保符合当地要求。
Conduct gap analysis on QMS documents during product transferring phase to make sure the compliance to local requirements.
•在产品转移项目中担任独立审查员，确认设计文件转移的合规性，并向相关职能部门提出改进意见。Acting as Independent Reviewer in product transferring project to confirm the compliance of design document transferring and raise improvement advice to related function.

经验 Experience
•有2年以上工作经验
At least 2 years of working experience.
•具有有源医疗器械行业工作经验。熟悉医疗器械NMPA要求、有源医疗器械检验和ISO13485，具有三坐标测试经验者优先。
Working experience in active medical device industry. Familiar with medical device NMPA requirements, active medical device test and ISO13485; having experience in CMM testing are preferred.
•具有管理委托生产经验者优先。
Entrusting production experience is preferred.

技能/认证 Skills/Accreditations
•持有内审员证书者优先。
Internal auditor certificate is preferred.
•良好的沟通、关系处理技巧和推进能力。
Good communication, relationship handling skills and pushing-forward capacity.
•具有良好英语能力（听、说、读、写）优先。
Good command in English (listening, speaking, reading and writing) is preferred.
•良好的计算机技能（Word、Excel、Power Point等）。
Good computer skills (Word, Excel, Power point etc.).

学历要求 Education Qualifications
•工程、机械、电子、自动化、质量管理、医疗器械或相关专业的学士学位及以上。
Bachelor’s degree or above in Engineering, Mechanism, Electronics, Automation, Quality Management, Medical Device or related filed.