南通招聘

Job Title: Quality Manager
职位名称：质量经理
Department: Quality Department, Devon Medical Products, Jiangsu
部门：质量部，戴闻医疗产品(江苏)有限公司
Reports To: Quality Manager of Devon Medical Products, Shanghai
汇报对象：质量经理，戴闻贸易（上海）有限公司
Location: East Half of 1-2F, Appt D2, Qinfeng High-Tech Business Incubator, 1, Qingfeng Road, Su-Tong Science & Technology Park, Nantong, Jiangsu Province, China 226017
工作地点：江苏省南通市苏通产业科技园清枫路1号清枫创业园（西区电子厂房）D2幢1-2层

Summary of Position

Quality Manager is responsible for ensuring that a product meets specific requirements for the company and its customers. Quality Managers handle legal compliances, customer expectations and coordinate activities in order to meet quality standards. Quality Managers ensure that the products or services meet federal state and local agency compliance standards. They also test and inspect the products and make any necessary adjustments. Quality Managers also handle any customer complaints and address any daily issues with other staff or corporate headquarters.


Essential Duties and Responsibilities

• Promoting quality achievement and performance improvement throughout the organization. Setting QA compliance objectives and ensuring that targets are achieved.

推动不断改进，提升公司的质量管理水平，完成既定的质量目标。

• Develop, implement, communicate and maintain the Company’s Quality Systems and Policies in compliance with quality system requirements, national and international standards and legislation.

负责建立、推行和维护公司质量体系，满足质量体系、国家标准、国际标准和法规的相关要求。

• Effectively interact with Production and Development teams to maintain product supply and help introduce new products.

配合生产和研发团队，积极参与日常生产控制和新品投产。

• Working with purchasing staff to establish quality requirements from external suppliers.

通过与采购团队的协作，建立和完善供应商管理流程。监督供应商的供货质量，督促供应商不断改进。

• Writing procedures, work instructions, test methods, inspection criteria and reports.

编写程序文件、作业指导书、测试方法、检验标准和测试报告。

• Bringing together staff of different disciplines and driving the group to plan, formulate and agree comprehensive quality procedures and quality plans.

召集各部门对质量体系文件和质量计划进行策划、组织编写和评审。

• Ensuring procedures and work instructions are properly understood, carried out and evaluated.

确保程序文件或作业指导书得以宣贯和执行，并根据实际情况，不断评估其适用性。

• Ensuring inspection criteria and test methods are properly understood, carried out and evaluated. Supervising the staff in carrying out tests and checks.

确保检验标准和检测方法得以宣贯和执行，并根据实际情况，不断评估其适用性。指导员工正确进行测试和检查。

• Manage and maintain the Company’s quality inspection and product release programs for incoming, FAI and in-process materials and components, processes and finished goods.

建立和维护产品检验和产品放行流程，规范进货、首件检验、过程和成品检验。

• Considering the application of environmental and health and safety standards.

负责推行环境、健康和安全相关标准在公司的运用。

• Setting up and maintaining documentation control procedures.

建立和维护公司质量体系文件和记录的管理流程。

• Establishing and maintaining nonconforming product control procedures.

建立和推行不合格品控制流程，负责牵头进行不合格评审。

• Working together with the team to handle customer complaints with the frame of regulation and customer requirement.

在法规的框架内，满足客户要求，妥善处理客户投诉。

• Leading the management team to identify nonconformities and potential nonconformities, implementing proper corrective and preventive actions(CAPAs) to prevent reoccurrences.

领导团队识别不合格和潜在不合格，采取适当的CAPA，防止再次发生。

• Liaising with external auditors and ensuring the execution of corrective action.

接待认证机构、政府监管部门的外部审核，维持公司ISO9001、ISO14001和ISO13485等体系证书。

• Monitoring performance by gathering relevant data and producing statistical reports.

进行质量数据采集、统计分析和报告。

• Identifying relevant quality-related training needs and delivering training.

负责识别有关质量的培训需求并开展培训。

• Maintaining awareness of the business context and company profitability, including budgetary control issues.

维护公司有效的运营和成本控制的执行。

Supervisory Responsibilities

Document Controller, IQC Engineer

Qualifications Required for Position

• B.S. + , Engineering and Science major preferred;

电子或电器专业，或其它理工专业，本科及以上；

• 3+ years related Quality experience;

3年及以上质量管理经验；

• Strong understanding and experience in Compliance, Deviations, Complaint, Non-Conformance and/or CAPA programs;

具有合规、偏差、投诉、NCR和CAPA实际工作经历；

• Familiar with processes of PCBA production;

熟悉PCBA、电子机械产品的装配；

• Experience in auditing and Authority inspections desirable;

有ISO9001、ISO14001和ISO13845质量管理体系认证和FDA工厂审核经验优先考虑；

• Computer skills: Microsoft Word, Excel and Outlook;

计算机能力：熟练运用Microsoft Word, Excel and Outlook；

• Fluency in English reading and writing;

流利的英语阅读和写作；

• Experience working in MNC Company strongly preferred;

有跨国公司工作经验，优先考虑；

• Good communication skills and supervisory experience strongly preferred;

良好的沟通、人际关系技巧及领导能力；

• 积极、创新、高效、细致、责任心。

Self-motivated, open minded, efficient, detail oriented, and high commitment to quality.

Work Environment

95 % office or factory work, 5% travel

戴闻医疗为医学界提供了创新，安全和经济有效的医疗产品。公司打造了一条创新型的医疗器械产品设计生产线， 旨在为全球范围内的医护人员和患者提供最大化的安全性。医疗保健行业的专业人员，分销商，制药业和患者都期待着戴闻医疗的创新，经济有效和高品质的医疗产品和解决方案。
戴闻医疗采用严格的质量管理体系向客户提供专业的医疗产品。公司通过ISO 9001:2000 以及 13485:2003的认证，生产设备符合美国FDA标准，确保了其生产线遵循了高品质，高可靠度，高性价比的严格标准。

我们的价值

戴闻医疗以严格按照业界标准的要求和规范著称，并始终坚持以下四原则：
安全
戴闻医疗始终为全球范围内，医护人员和患者的安全的最大化而奋斗，并通过这样促进医疗水平的提高。
创新
每天，在医学界都有无法预料的障碍和新的要求。 对于各种不同的研发程序，生产过程和专利审查中的问题，戴闻医疗都试图寻求突破性的解决方案。
质量
戴闻医疗采用一个全面的质量管理体系和优质的客户服务政策，以确保客户对其产品始终都能保持满意。
价格可承受性
戴闻医疗相信，医疗服务的提供者或病人都不应感到自己是被迫在质量与价格可承受性之间做出选择。这也就是为什么公司致力于利用一切市场资源，提供具有经济有效和可负担得起的产品和解决方案。