上海招聘

职位描述：
1、负责质量管理体系的建立、推行和维护，以符合FDA QSR, ISO13485及欧盟医疗器械指令的要求。
2、定期向管理层报告质量管理体系的运行情况。
3、负责供应商质量管理和审核。
4、负责产品放行批准的制定和执行。
5、负责组织不合格品评审。
6、根据技术规范的要求，制订新产品的质量标准。
7、负责准备和协调与质量管理体系有关的审核或检查。
8、负责纠正预防措施的实施和验证。
9、负责与质量管理体系有关的数据分析。
10、负责客户抱怨的处理。
11、负责质量管理体系的策划。
12、负责产品设计开发的评审， 风险管理和更改控制。
13、参与过程验证。
14、参与质量管理体系内审和管理评审。

工作胜任要求：
1、本科以上学历；
2、5年以上质量管理体系运行经验，一次性医疗器械或塑料制品行业工作经验优先;
3、国家注册质量工程师优先；
4、具有ISO9001/ISO3485/ISO4001 内审员资格优先；
5、较强的领导力；
6、良好的口头及书面沟通能力；
7、中英文流利。

Responsibilities (fundamental job duties):
1.Be responsible for the establishment, execution and maintenance of the quality management system, which is in compliance with FDA QSR, ISO 13485 and MDD 93/42 EEC.
2.Report to top management on regular basis the performance of the quality management system.
3.Be responsible for supplier quality audit and management .
4.Be responsible for defining product quality criteria and standard and final release.
5.Be responsible for nonconforming product review.
6.Base on the technical specification, set up quality standards and specifications for new products.
7.Be responsible for the coordination and preparation of external audits or inspections to quality management system.
8.Be responsible for the implementation and verification of corrective and preventive actions.
9.Be responsible for quality management system related data analysis.
10.Be responsible for customer complaint handling.
11.Be responsible for quality management system planning.
12.Responsible for product design and development review, risk management and change control.
13.Participate in process validation.
14.Participate in quality management system internal audit and management review.


Minimum Requirements:
1.Bachelor degree or above;
2.5+ years relevant experience in quality management system, with experience in single use medical device or plastic products industry is a plus；
3.China Registered Quality Engineer is a plus;
5.ISO9001/ISO13485/ISO14001 internal auditor is a plus;
6.Strong leadership;
7.Good communication skills (both verbal and written);
8.Be proficient in both English and/or Mandarin Chinese. 举报 分享

上海禹康医疗器械有限公司是一家专门从事医疗器械耗材出口的公司，位于上海市徐汇区。工厂设在江苏苏州。产品主要销往欧美等国，与国内外多家企业建立了良好的信誉合作关系。现因业务发展需要诚邀您的加入，我司将为您提供施展才华的平台、发展空间。