职位描述:
1.Develop, manage and maintain quality systems and related procedures to ensure that the company's production processes and products meet the requirements of applicable standards & regulations and continuously to improve; Formulate the company's quality management systems and monitor the implementation;
开发、管理及维护质量体系以及相关程序以确保公司的生产过程及产品符合适用标准及法规的要求并持续改进;拟定公司质量管理的各项制度并监督执行;
2.Manage the quality department and lead the whole quality team to carry out the quality daily work including overall quality control and management of incoming materials, production processes and finished product inspection;
管理质量部门,带领整个质量团队开展质量日常工作包括来料、生产过程和成品检验的全面质量控制及管理;
3.Approval of finished device release;
批准成品放行;
4.Confirm the applicable quality standards and inspection items for the products, confirm the equipment and inspection procedures required for the inspection; Nonconformity review and disposition.
明确产品适用的质量标准和检验项目,明确检验所需设备及检验流程;不合格产品的评审和处置;
5.Implement quality management systems into the R&D and production processes to ensure that product development and production can meet regulatory and company system requirements.
在研发和生产过程中贯彻质量管理体系,以确保产品的研发和生产符合法规和公司体系要求。
6.Manages certification system for suppliers;
管理供应商的评估系统;
7.Take lead of internal and external audit jobs and problem tracking & improvement, including prepare documents for management review and follow-up of corrective and/or preventive actions; Follow up of non-conformity of external audits and make sure to complete rectification within the time limit; Establish and maintain good public relations with the supervision departments;
主导内外部审核工作以及问题跟踪与改进,包括准备管理评审的资料及体系方面的纠正和预防措施进行跟进;针对外审发现的不符合项的整改落实,确保在规定时限内完成整改;建立和维护与监督管理部门良好的公共关系;
8. Regularly analyze various kinds of quality data, evaluate the operation of the quality system, rectify and solve any quality problems.
定期分析各项质量数据、评估质量体系的运行情况,并对存在的质量问题进行整改和落实。
9. Handling customer complaints, monitoring of adverse quality events, find out hidden quality problems of products etc., reporting to top management of the effectiveness of the quality management system and voice out improvement needs if any;
处理有关客户投诉情况、不良事件监测情况、发现产品存在的质量隐患等,向企业决策层报告质量管理体系运行的有效性和提出任何改进的需求;
10. Regularly hold quality meetings with related departments and develop continuous improvement programs to gradually improve the production process and quality level of the products;
定期与各部门召开质量会议,制定持续改善方案,逐步提高产品生产工艺与质量水平;
11. Assist in risk management activities and failure mode analysis to ensure compliance, assist in the identification of the cause of failure for the problem products, and implementation of CAPA;
协助开展风险管理活动及失效模式分析确保合规,协助问题产品失效原因的确认,以及CAPA手段的实施;
12. Conduct relevant training and quality awareness training to enhance the quality awareness of all employees;
进行相关规范和质量意识的培训,提升公司全体员工的质量意识;
13. Take the role of Management Reprehensive of the company;
担任公司的管理者代表;
14. Responsible for planning, organizing and assisting various quality management activities, such as product registration, ISO certification, etc.
负责策划、组织及协助各种质量管理活动,如产品注册、ISO认证工作等;
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任职要求:
1. Bachelor degree or above, graduated from science and engineering major;
本科及以上学历,理工科专业毕业;
2. More ...
工作地点:
广东中山市小榄镇中山市全康医疗科技有限公司-东南门