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QA Manager - Taicang

1.Job Purpose 工作目的

Responsible for managing the quality assurance, quality control, so that company objectives are met.

 

2.Knowledge and Skills required 学历及技能要求

  1. BS degree or equivalent
  2. At least 7 years quality experience in a manufacturing as quality management lead
  3. English skilled and able to communicate effectively in English
  4. Experienced regarding ISO9001.
  5. Experience regarding ISO1348
  6. Regulatory experience regarding medical devices in domestic and international markets.
  7. Familiar with ISO 14001&ISO 18001.
  • 大学本科学历或同等学历
  • 至少7年以上生产企业和质量管理经验
  • 英语流利
  • 熟悉ISO 9001
  • 熟悉ISO 13485
  • 具有国内和国际市场医疗器械法规经验
  • 熟悉ISO 14001&ISO 18001

3.Principle Job Accountabilities 工作职责描述

  1. Be responsible for communication with RB Group Quality Top Management for product quality and quality management system.
  2. Report product quality performance issue including either quality problem or achievement to RB Group Quality Top Management and be responsible for providing CAPA for any quality issue if required to ensure the product quality are protected.
  3. Be responsible for implementing RB quality policy to ensure both product quality and quality management system are implemented successfully.
  4. Overall responsibility for the implementation and maintenance of the quality management system in accordance with ISO 9001 and ISO 13485.
  5. Oversees the release of raw materials, in-process goods, and final product which complies with company standards.
  6. Oversees the internal quality auditing system to ensure compliance to ISO 13485.
  7. Oversees induction training of new employees in regard to quality and GMP requirements.
  8. Assumes overall responsibility for the corrective action and preventive action programs to drive continuous improvement in order to improve quality, safety, and reduce cost.
  9. Manages the handling of customer complaints according to site and Group requirements.
  10. Assists the company’s regulatory affairs to ensure compliance in domestic and international markets.
  11. Responsible for adverse incident reporting of medical devices according to company procedure.
  12. Holds monthly communication meetings to ensure QA/QC staff is updated timely in regard to company policies and procedures.
  13. Monitor compliance regarding environmental work instructions and policies in order to comply with ISO 14001 and to achieve site environmental objectives.
  14. Monitor compliance with company health & safety procedures and policies to ensure a safe workplace and to achieve site health and safety objectives.
  15. Ensure, so far as is reasonably practicable, the site and all associated work activities are safe and without risks to Health and Safety, and are carried out in accordance with current legislation, codes of practice, company policy and procedures.
  16. Contribute to the establishment, implementation, and improvement of ISO14001 environmental and ISO 18001 health and safety management systems including the establishment of site environmental and health and safety objectives.
  17. Is Quality Management System representative.
  18. Familiar with the relevant laws and regulations of medical equipment, with the practical experience of quality management, has the ability of the practical problems in production management and quality management to make the right judgment and processing.
  19. Maintain local QMS to comply with RB global QMS and local regulatory requirement.
  • 负责与利洁时集团质量高级管理层沟通产品质量表现和质量管理体系。
  • 向利洁时集团质量高级管理层汇报包括质量问题和质量成果等产品质量相关的表现情况,根据要求负责提供针对质量问题的CAPA,确保产品质量得以保证。
  • 负责执行利洁时质量方针,确保产品质量和质量管理体系有效执行。
  • 全面负责质量体系的实施和保持,使之符合ISO9001和ISO13485的要求。
  • 监督管理符合公司标准的原材料、在制品和最终产品的放行。
  • 监督管理内部质量审核体系,确保符合ISO13485的要求。
  • 全面负责新员工进行有关质量和GMP要求的入职培训。
  • 全面负责纠正措施和预防措施,推进持续改进,以提高质量、安全并降低成本。
  • 按照工厂和集团的要求管理客户投诉的处理工作。
  • 支持协助公司的法规相关事宜,确保公司符合国内和国际市场的要求。
  • 按照公司程序规定负责医疗器械不良事件的报告工作。
  • 召开月度沟通会议,确保质保/质控的人员及时获得有关公司政策和程序规定的最新信息。
  • 监督有关环境方针和指导的完成情况,从而确保ISO14001体系以及达成工厂环境目标。
  • 监督健康和安全程序和方针的完成情况,从而确保安全的工作场所以及达成工厂健康和安全目标。
  • 在合理可行的基础上,确保工厂和所有与工作相关的活动的安全,没有健康和安全风险,并确保所有活动符合目前的法规、业务守则,公司规定和程序的规定。
  • 促成ISO14001环境管理体系和ISO18001健康和安全管理体系的建立、实施和改进,包括工厂环境、健康和安全目标。
  • 作为公司质量管理者代表。
  • 熟悉医疗器械相关法律法规,具有质量管理的实践经验,有能力对生产管理和质量管理中的实际问题作出正确的判断和处理。
  • 负责维护当地的质量管理体系符合集团要求及当地法规要求。


Job Segment: Medical, Medical Device, Medical Equipment, Healthcare

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