职责描述: 工作职责(Responsibilities): 1. 维护并完善公司各管理体系,与各部门一起完善体系文件的制定与修改。 Maintain and improve company management system, work together with each department to establish and update system documents. 2. 日常质量体系运行的监督,建议的处理与跟踪。 Monitor quality system operation, conduct and follow suggestion. 3. 监督各职能部门质量体系运行情况。 Oversee quality management system operation status. 4. 主导公司内审的策划和组织,并对纠正措施进行指导和验证。 Plan and organize internal audit, follow the corrective action and the verification. 5. 体系推行并落实执行和文件控制管理。 The system promotes and carries out an execution. 6. 体系管理知识的内部宣传和培训。 Internal publicity and training of quality management knowledge. 7. 外审和客户审核的接待和跟进。 External audit and customer audit follow. 8. 产品认证、体系认证以及审员注册评定管理。 Product certificate and system certificate, internal auditor assessment and training. 9. 处理上级交办的其他事宜。 Deal with other assignments assigned by superior.
任职资格(Qualification) : 1. 本科及以上学历。 Bachelor degree above. 2. 3年以上质量体系管理相关工作经验,具备ISO13485和QSR820等医疗行业质量体现管理经验者优先。 Above 3 years relative QMS working experience and priority to ISO13485 & QSR820 medical quality system. 3. 良好的英语听说读写能力。 Good command of English listening, speaking, reading and writing.