南平招聘

1. Principal Duties and Responsibilities (General Summary, essential functions and authorities, etc.) 主要工作职责（基本概况，主要功能，权限等）

1. As assistant QMS manager, work together with the team to maintain and improve quality system compliance in JJMS as per ISO13485:2003, J&J Quality Policy, other JJ cooperate requirements, and regulatory requirements.
   作为质量体系团队一员，根据ISO13485:2003、强生质量方针、强生总部要求以及其他法律法规要求，与团队一起维护并改进JJMS质量体系。

   1. Facilitate Quality Management. Representative to conduct Management Review for JJMS. Also prepare management review on responsible area. Be responsible for Management Review Report and MAP preparation. Be responsible for tracking MAP completion status.
      协助质量经理完成JJMS的管理评审，准备所负责区域的管理评审内容。负责管理评审报告和管理评审行动项的准备，并跟踪管理评审行动项的完成情况。

   2. Act as linkage with the notify body such as BSI. Coordinate external audit with Q&C Dir and on-site Q&C head to have proper arrangement on handling ISO audit, HA audit, JJRC audit, etc. Be responsible for tracking audit finding action plan status.
      作为与公告机构，如BSI，之间的链接，与现场的质量经理共同协调、准备ISO外审，监管部门审核，JJRC审核及其他审核。负责跟踪审核发现项纠正计划的状态。

   3. Set-up internal audit plan, oversight the implementation of the audit plan. Timely escalate critical issue to upper management.
      协助QMS经理共同制定内审计划，并监督内审计划的完成情况。如有严重事件，及时向上层汇报。

   4. Maintenance and improvement of document/record control system.
      维护并改进文件/记录控制系统。

   5. Monitoring and collecting external standards and regulation published related to JJMS quality management system. Work with related function on identifying existing gaps. Improve quality system per updated requirements. Report to upper manager for any management actions required.
      监控收集与JJMS质量体系相关的外部法律法规和标准的颁布。与相关部门一起识别差距，根据更新的要求改进质量体系。向上级质量经理汇报需要进行管理层行动的事件。

   6. Support Q&C functional head on reviewing and updating Quality Agreement with JNJ affiliates and international DCs.
      支持质量部各职能领导共同审阅、更新与JNJ母公司和国际物流中心的质量协议。

   7. NC/CAPA/Change Control Application. Monitor the NC/CAPA/Change Control Application status and escalate any critical issue.
      作为NC，CAPA和CCA的审阅人和批准人，监控NC，CAPA和CCA的情况，上报严重事件。
      
      Maintain CAPA procedure, participate CAPA investigation, oversight the completion of CAPA case. Provide summary for management review and/or sourcing visit.
      维护CAPA流程，参与CAPA调查，跟踪CAPA完成情况。为管理评审和/或母公司访问提供CAPA汇总信息。

   8. Be reviewer and/or approver for GOP and QMS related SOP and ensure the compliance of both the content and format with related standards/regulations.
      作为GOP和QMS相关SOP的审阅人或批准人，确保文件内容和格式符合相关法律法规和标准的要求。

   9. Maintain and communicate the quality policy, coordinate the establishment, breakdown, monitoring and measurement of the quality objectives. Coordinate the quality planning activities within JJMS when necessary.
      负责质量方针的维护和宣贯，负责协调质量目标的制定、分解、监视和测量。必要时，负责协调质量策划的进行。

   10. Maintain risk management procedure, provide training to process owner to complete the necessary FMEA report.
       维护风险管理流程，提供培训给流程负责人以完成需要的FMEA报告。

2. Responsible for regional or global system data maintenance and reporting such as Curve, Matrix Studio, etc.
   负责亚太或全球系统中体系相关数据的维护与上报，如Curve、Matrix Studio等。

3. Other responsibilities defined in written procedures.
   流程中规定的其它职责。

4. Fulfill other tasks assigned.
   其他指定的工作任务。
   
   

Basic Requirement, including Education and/or Knowledge and/or Training and/or key Relevant Experience required.
基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）

1. Bachelor Degree on pharmaceutical, medicine, medical device or related subjects.
   药学、医学、医疗器械相关专业本科学历。

2. At least 3 years’ experience in quality compliance or related areas in medical device or pharmaceutical.
   至少2-3年以上的医疗器械或药厂质量管理体系符合性或相关领域的经验。

3. Good communication skills and leadership
   良好的沟通和领导能力

4. English fluent in reading, writing, oral and listening
   流畅的英文听说读写能力

5. Familiar with routine operations of computer and software
   熟练操作计算机常用功能

6. Experience in team management is a plus.
   有团队管理经验者优先。
   
   

Skill Sets and/or Training and/or Certification for the Special Position
特殊岗位的技能和/或培训和/或证书要求

1. Ability to build collaboration and teamwork across functions.
   有能力跨部门进行合作与团队工作。

2. Critical thinking and decision-making skills.
   批判性思维与决策技能。

3. Demonstrated project management skills with strong ability to negotiate and influence in a comprehensive environment.
   在复杂环境中凭借有力的沟通与影响能力的项目管理技巧。

ISO 13485 or 9001 auditor certification; lead auditor certification is preferred. 有ISO 13485或9001审核员资质；主任审核员资质更佳。

强生（上海）医疗器材有限公司诚聘