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QMS/RA Manager, Quality

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Description

Primary Purpose

  1. Lead the QMS Management for Phillips-Medisize China facilities 领导辉美中国各工厂的质量体系事务
  2. Lead the RA Management for Phillips-Medisize China facilities 领导辉美中国各工厂的质量相关法规事务管理
  3. Support the Risk Management process operation for Phillips-Medisize China facilities 支持辉美中国各工厂的风险管理流程运行
  4. Management of Training Organization Phillips-Medisize China facilities 辉美中国培训组织管理

What You Will Do In Your Role

1. Be partner of the site Quality Manager to lead the QMS/RA/Risk team to manage the QMS related activities, RA, and risk process according to the global system requirement and site-specific business requirement. 作为工厂质量经理的业务合作伙伴,领导质量体系/法规/风险小组成员按照全球体系管理要求及各工厂端特殊需求对各工厂的质量体系,法规事务,和风险管理流程进行管理。 The QMS activities include below areas, but not limited: 质量体系事务包含但不限于以下方面

  • Participate in global system management activities 参与全球体系管理活动
  • Quality system establishment, change, optimization, and improvement 质量体系建立,变更,优化及改进
  • All kinds of quality audits management and follow up 内外部审核安排及追踪
  • QMS knowledge advertising 质量管理体系知识传播
  • Quality culture deployment supporting 质量文化推广支持
  • All China facility Quality KPI collection, collation, review and improvement opportunity proposing 各工厂质量体系KPI 收集整理和评审和改进建议的提出

The RA activities include below areas, but not limited: 法规事务包含但不限于

  • New RFQ supporting on Regulation/QMS requirement review新产品法规/体系要求评审
  • Product registration handling 产品注册事务管理
  • Quality system compliance assurance for the regulated product 监管产品质量管理体系法规符合性保障

The risk management activities include below areas, but not limited: 风险管理包括但不限于

  • Risk management process deployment 风险流程要求部署
  • Risk management plan/report review 风险管理计划/报告评审
  • Risk management knowledge advancing 风险管理知识传播

2. Training process management 培训流程管理

3. Play the role of supervisor to manage a team, including recruiting, talent development, performance review etc.承担主管职责,负责团队日常管理,包括招聘,人才发展,绩效评估等。

4. Follow EHS related laws, regulations and company's EHS related management regulations, timely report potential risk, and propose safety improvement suggestions; For management position, be responsible for EHS management of the department/team. 遵守环境和职业健康安全相关法律法规,遵守公司环境和职业健康安全相关管理规定,及时上报身边安全隐患,并提出安全改进建议;若为管理岗位,需负责本部门、团队的环境和职业健康安全管理

5. Other duties as assigned by supervisor. 其他由主管指派的任务

The Experience You Will Bring

Requirements:

  • Minimum of a Bachelor’s degree with a concentration in quality, engineering, or life science (e.g. chemistry, microbiology). 最低学士学位,专注于质量、工程或生命科学(如化学、微生物学)。
  • Open minded, embrace challenge and transformation 思想开放,勇于接受挑战和变革
  • A strategic and tactical person with the ability to build positive relationships at all levels. Strong technical and problem-solving skills required具有在各层级建立积极关系的战略战术能力,及较强的技术和问题解决能力
  • Strong written, verbal, organizational, and interpersonal communication skills 较强的书写,口头表达,组织,及人际沟通能力
  • Project management skills 项目管理能力
  • Ability to work in a fast-paced work environment that is matrixed globally 能够在全球矩阵化的快节奏环境中工作
  • Good analytic senses 良好的分析思维
  • Excellent audit skill 出色的审核技巧
  • Master of CAPA CAPA 大师
  • Knowledge of ISO14971 and risk management ISO14971及其他风险管理知识
  • Should have direct expert knowledge in both medical device and pharmaceutical RA product submission lifecycle activities应具备医疗器械和带药产品生命周期活动内的法规递交的直接专业知识。
  • Experienced in Quality/Compliance environment, Played the role of QMS/RA leader. 具备质量/合规环境工作经验,担任过质量体系及法务领导
  • Proficient experience with the following regulatory/notified body requirements: 至少精通以下法规及公告机构要求 a. FDA CFR Part 11, part 820; Part 210 and 211; b. ISO 9001:2015 c. 13485:2016 d. NMPA and EU Medical Device Regulations is a plus
  • Significant experience in an overall cGMP / GXP operating environment 在整体 cGMP / GXP 运营环境中拥有丰富的经验
  • Managed FDA/NMPA audits. 组织领导FDA/NMPA 审核经验

What Will Put You Ahead

  1. Master 硕士
  2. ISO13485 Lead auditor 13485体系主任审核员
  3. Strong Validation skill 验证技能
  4. FDA/NMPA/EU class II/III medical device registration experience. FDA/NMPA/EU 二类及三类医疗器械注册经验
  5. Be familiar with the molding, printing, sterilization and high-automation secondary process, SAP system. 熟悉注塑,印刷,灭菌及二次加工组装过程。熟悉高自动化组装过程和SAP系统

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