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Subject Matter Expert for Medical Quality System
2 months ago
Job Summary
1. Lead QMS standards establish, risk assessment and internal Audit for medical devices products.
领导医疗器械 QMS 标准的建立、风险评估和内部审核。
2. Lead to prepare and coordinate the medical devices QMS standards external audits and certification activities.
领导准备和协调医疗器械 QMS 标准的外部审核与认证活动。
3. Provide quality technical support to medical devices production, e.g. FMEA, Control Plan, CTQ, equipment/software validation, etc.
为医疗器械产品的生产提供质量方面的技术支持，例如 FMEA，控制计划，关键质量特 性，设备/软件的验证鉴定等。
4. Lead/support on statutory and regulatory requirements compliance for medical devices products.
领导/支持与医疗器械产品相关的法律法规的符合性。
5. Conduct medical devices QMS document review and actions follow up.
执行医疗器械 QMS 文件的评审和措施跟进。
6. Provide training and knowledge sharing for medical devices QMS requirements. 针对医疗器械 QMS 的要求提供培训和知识分享。
7. Follow QA SME Manager’s other job assignment.
执行 QA SME 经理安排的其他工作任务。
JOB DESCRIPTION
1. QMS Standards Establish and Internal Audit
质量管理体系标准的建立和内部审核
1.1 Lead and coordinate the medical devices QMS standard establish in the company, e.g. ISO 13485 and other medical devices related requirements.
领导和协调公司医疗器械质量管理体系标准的建立，例如 ISO 13485 以及其他医疗器 械相关要求。
1.2 Conduct risk assessment for workcell & QMS Process and convert into QMS annual internal audit plan, e.g. ISO 13485, ISO 9001, etc.
对工作坊和 QMS 过程进行风险评估，并转化为 QMS 年度内部审核计划，如 ISO 13485、ISO 9001 等。
1.3 Lead team to conduct regular ISO 13485 QMS internal audit.
带领团队定期进行 ISO 13485 质量管理体系内部审核。
1.4 Lead team to conduct ISO 13485 Management Review.
带领团队进行 ISO 13485 管理评审。
1.5 Conduct special audit, such as Change Management, CSR audit, baseline audit, etc.
执行专项审核，如变更管理、客户特殊要求审核、基准线审核等。
1.6 Conduct regular plant level JOS audit.
进行工厂层面定期的 JOS 审核。
1.7 Supervise team to follow up QMS internal audit (especially for medical device business) lesson learnt and work out the systematic improvement action plan in closed loop.
监督团队跟进质量管理体系内部审核(特别是针对医疗器械业务)的经验教训，制定系 统性的闭环改进措施。
2. QMS External Audit and Certification
质量管理体系外部审核和认证
2.1 Lead team to prepare and coordinate ISO 13485 and the other medical devices related external 3 rd party audit and certification, e.g. FDA, GMP, CNCA, etc.
带领团队准备和协调 ISO 13485 以及其他医疗器械相关的外部第三方审核和认证，如 FDA、GMP、CNCA 等。
2.2 Take part in and support the other QMS standards external audit, e.g. ISO 9001.
参与并支持其他质量管理体系标准的外部审核，如 ISO 9001。 2.3 Assist workcell to get preparation for customer audit.
协助工作坊准备客户审核。
2.4 Supervise team to follow up QMS external audit (especially for medical device business) lesson learnt and work out the systematic improvement action plan in closed loop.
监督团队跟进质量管理体系外审(特别针对是医疗器械业务)的经验教训，制定系统性 的闭环改进措施。
3. Medical Devices Business Technical Support
医疗器械业务技术支持
3.1 Product Quality technical support for medical devices production process, such as review/guide FMEA, Control Plan, CTQ, etc.
提供医疗器械生产过中产品质量方面的技术支持，如 FMEA、控制计划、CTQ 等的评 审/指导。
3.2 Guide team to conduct production equipment and software validation (i.e. IQ/OQ/PQ buy off) according to ISO 13485 or other medical devices related requirements.
根据 ISO 13485 或其他医疗器械相关要求，指导团队进行生产设备和软件验证(即 IQ/OQ/PQ 验收)。
3.3 Support team on customer special requirements (CSR) review and convert to internal process when necessary.
支持团队进行客户特殊要求(CSR)评审，必要时转化为内部流程。
3.4 Drive and support workcell team to collect the best practices and lesson learning for medical devices business.
推动和支持工作坊收集在医疗器械业务方面的最佳实践和经验教训。
3.5 Provide support for workcell quality team’s headcount sizing for medical devices.
为医疗器械工作坊内质量团队的人力规划提供支持。
4. Lead/Support on Statutory and Regulatory Requirements Compliance
领导/支持法律法规要求的符合性
4.1 Lead to team to establish the process of statutory and regulatory requirements compliance.
带领团队建立法律法规要求符合性的流程。
4.2 Guide workcell team to collect, understand and implement medical devices related statutory and regulatory requirements.
指导工作坊收集、理解和实施医疗器械相关法律法规要求。
4.3 Provide support to workcell team on government required medical devices registration and authorization application activities.
根据政府要求的医疗器械注册和许可申请活动向工作坊提供支持。
4.4 Provide support for customer complaint handling based on corrective and preventive actions process, guide workcell team to support customer for adverse events or issuance of advisory notices to regulatory authorities.
根据纠正和预防措施流程为客户投诉处理提供支持，指导工作坊协助客户处理不良 事件或向监管机构发出忠告性通知。
5. QMS Document Review
质量管理体系文件评审
5.1 Conduct global QMS document gap analysis review and provide training if needed, especially for Healthcare/Medical sector related document.
执行总部质量管理体系文件差距分析评审，必要时进行培训，特别是针对健康/医疗 事业部的相关文件。
5.2 Lead team to integrate Global Healthcare/Medical sector related documents into site process/documents.
领导团队将总部健康/医疗事业部相关文件整合到工厂流程/文件中。
5.3 Simplify, Optimize and Standardize the process and revise QMS related document.
简化、优化和标准化流程，修订质量管理体系相关文件
5.4 Lead cross functional team to establish and maintain baseline for medical devices business.
领导跨职能团队建立和维护医疗器械业务的基准线。
6. Training and Knowledge Sharing
培训和知识共享
6.1 Conduct training about ISO 13485, relative statutory and regulatory requirements, or other medical devices related standards (e.g. FDA, GMP, CNCA, etc.), for newcomer or per operations required.
根据新员工或业务需求进行 ISO 13485、相关法律法规要求或其他医疗器械相关标准 (如 FDA、GMP、CNCA 监管要求等)的培训。
6.2 Establish the cookbook for medical devices QMS.
建立医疗器械质量管理体系指南。
7. Digital Solution
数字化解决方案
7.1 Work out digital solution for QA function or workcell processes and tasks to improve the process quality and efficiency.
制定 QA 部门或工作坊流程的数字化解决方案，提高流程质量和效率。
8 Follow QA SME Manager’s other job assignment.
执行 QA SME 经理安排的其他工作。
REREQUISITES
1. Bachelor or above, worked in Medical Device industry with minimum 10 years quality control or quality management system experience, minimum 4 years’ experience of team leader. Medical or science and engineering related major is preferred.
本科以上学历，至少 10 年医疗器械行业质量控制或质量管理体系工作经验，其中至少 4 年团队领导经验。医学或理工科相关专业优先。
2. Proficiency in ISO 13485 and domestic/overseas relative statutory and regulatory requirements are the basic, if candidate also has proficiency in FDA, GMP, CNCA, etc. will be priority.
精通 ISO 13485 及国内外相关法律法规，熟悉 FDA、GMP、CNCA 监管等要求者优先。
3. Able to communicate clearly and effectively in both verbal and written media.
能够用口头和书面媒体进行清晰有效的沟通。
4. Good at problem-solving skill (e.g., PDCA，8D CAR, Lean Six Sigma tools, etc.).
具备解决问题的能力(如使用 PDCA,8D CAR，精益六西格玛工具等)。
5. Skillful at excel data analysis, candidate can use SQL, power BI, python, etc. data analysis tools is preferred.
熟练使用 excel 数据分析, 会使用 SQL、power BI、python 等数据分析工具者优先。
6. Fluent in oral and written English.
英语口语和书面表达流利。
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