职位详情
医疗器械质量经理
2.5-3.5万·15薪
杭州新中大科技
资阳
10年以上
本科
05-01
工作地址

中国牙谷科创园

职位描述

1. 组织公司质量管理体系的建立、运行、维护,并通过第三方认证;

2. Establish, maintain of the company's quality management system, and pass the third-party certification;负责组织公司质量管理体系的内部审核、客户审核、第三方认证审核、药监局产品注册审核和生产许可证认证审核;

Responsible for organizing the internal audit, customer audit, third-party certification audit, product registration audit of NMPA and production license certification audit;

3. 协助管理者代表策划管理评审会议,负责编制管理评审计划、管理评审会议的输入和输出报告;

Assist the management representative to plan the management review meeting, and be responsible for initiating management review plan and manage the input and output reports of the management review meeting;

4. 组织公司质量检验标准、检验流程的制定,并监督其运行;

Organize the formulation of the company's quality inspection standards and inspection procedure, and monitoring operation;

5. 组织质量管理部管理制度、工作流程的编制、评审和监督运行;

Organize the preparation, review and supervision of the quality management system and workflow of the quality management department.

6. 负责组织公司质量事故的调查处理;

Responsible for organizing the investigation and handling of the company's quality accidents.

7. 审核质量报告,并作出分析与改善对策;Review the quality report, and make analysis and improvement countermeasures;

8. 负责组织客诉问题的处理、改善和监督处理方案和改善方案的执行;

Responsible for organizing the handling of customer complaints, improving and supervising the implementation of the disposition plan and the improvement plan;

9. 负责本部门工作计划的制定、工作总结和分析;

Responsible for initiating work plan of the quality department, summarize it and analyze it;

10. 负责组织实施本部门的质量记录、数据的归档工作;

Responsible for organizing and implementing the archiving of quality records and data of the department;

11. 负责下属工作计划方案、报告报表、总结、申请等的审核和工作安排、指导、督促、检查;

Responsible for management subordinates, guidance, supervision and inspection of work plans , reports, summaries, applications, etc.

12. 负责本部门人力资源的规划、评估及任用;

Responsible for developing department, including evaluation, planning, recruiting, appointment.

13. 负责部门间、部门内工作沟通、协调与配合;

Responsible for internal and external communication, coordination and cooperation.

14. 完成上级安排的其它工作

14.Complete other tasks assigned by director.
任职要求:

1

专业知识/技术任职资格

Professional knowledge/technical qualification

精通GMP,ISO13485, MDSAP等质量体系

ISO13485内审员资质

Master GMP, ISO13485, MDSAP and other quality system.

Got ISO13485 certificated as an internal auditor

2

专业技能

Professional skills

熟悉Word、 Excel、PPT等微软办公工具

英文听说读写能力俱佳

Be familiar with Word, Excel, PPT and other Microsoft office software.

Good English listening, speaking, reading and writing skills.

3

能力素质

Capability

良好的沟通能力、自我驱动能力,良好的学习能力,良好的分析和解决问题能力,良好的领导力,抗压能力强

Good communication skills, self-driven ability, good learning ability, good analytical and problem-solving skills, good leadership, strong ability to work under pressure

4

工作经验/年限

Working experience/years

10年以上工作经验, 6年以上质量工作经验

10+ years working experience, 6+ years in quality.

5

其他(学历等)

Others (education, etc.)

本科以上学历,生物医学工程. 电子机械工程等理工科背景

Bachelor's degree or above in biomedical engineering. Background in science and engineering such as electrical and mechanical engineering

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