南京招聘

Reporting to : Senior Quality Engineer 高级质量工程师

Duties & Responsibilities岗位职责

· Review and distribute the new/revised document as per document change request.根据文件变更申请审核并分发新文件以及变更后的文件
· Establishes and maintains a central repository, including history files, for all controlled Quality & Regulatory documents and records. 建立并维护文档包括历史文档、所有受控质量及法规文件及记录
· Perform various duties essential to the implementation and maintenance of a regulated documentation system, including coordinating efforts for the control of new and updated Quality System procedures for ISO/QSR. 执行各方面必要的职责实施并维护法规文件体系，包括有效协调ISO/QSR新的QMS的管控及更新
· Ensure the consistency and quality system of Medical Device product, process, and policy documentation.确保医疗器械产品的质量体系、过程和方针文件的一致性
· Follow up the internal audit and external audit findings to ensure the closure timely. 跟踪内审及外审不符合事项并确保及时关闭
· Responsible for NEO Induction Training.负责新员工的质量相关要求的培训
· In-charge of review the DHR and batch record.负责审核DHR以及批生产记录
· Support QA Dept. for the daily grind, including office supply requisition and checking attendance each month by system.配合本部门日常工作，包括办公用品的请购及每月考勤系统的确认
Requirements岗位要求
· Diploma or above. Min 2 year relevant experience.大专以上学历，至少,2年以上相关工作经验
· Familiar with computer skill and communication skill.熟练使用办公软件及良好的沟通能力
· Be good at English reading, writing speaking and listening.良好的英语听说读写能力
· Knowledge of ISO9001 ISO13485 and certificate with internal audit 掌握ISO9001和ISO13485知识并具备内审员资格证书
· Knowledge of China standard concern with Medical device manufacturing.熟悉并了解中国医疗器械相关法律法规知识

任职要求
1.大专以上学历，

2.2年以上公司相关工作经验；
3.熟悉微软办公应用软件，如word, Excel 等；
4.工作负责、主动，注重细节；
5.较强的人际沟通能力；
6.良好的英文书写、阅读能力及普通表达能力

                                   法福来医疗科技（江苏）有限公司

Welcome to join Forefront Medical Technology (Pte) Ltd
Forefront, an integrated medical device contract manufacturer, provides collaborative product design and development, rapid SLS prototyping, tool making, injection moulding and extrusion, clean room scalable assembly and packaging, testing, sterilisation and global logistics. Forefront has the experience and expertise to manufacture original devices or custom-design a new product from a conceptual drawing into a completely manufactured, packaged and sterilised product, and finally ready for global shipment. Our integrated capabilities bring customers’ new products to market quickly, while providing confidentiality of new designs and protection of intellectual property.

Forefront’s core values focus on customer needs, engineering excellence and responsiveness. Our rigorous quality policy underscores “Fitness For Purpose with Continuous Improvement” and promotes a working environment where every customer and employee are valued and respected.
Forefront Medical Technology (Jiangsu) Co., Ltd, newly set up in 2012 in Changzhou, is a subsidiary of our Singapore Company.
We welcome you to be part of the Forefront team.

法福来医疗科技（江苏）有限公司（下称“法福来”）注册于2012年，系新加坡独资企业。该公司是Vicplas国际有限公司和Venner资本公司的合资企业Forefront Medical Technology (Pte) Ltd在中国投资的企业。
作为一个不断致力于医疗设备制造的公司， 法福来公司专注于组件的制造和组装，这些组件是由如液态硅橡胶和高增塑聚氯乙烯加工而成的。
随着企业的发展壮大，我们诚邀愿意与企业共同成长的人才加入我们的团队，公司除严格信守国家、地方法规为提供社医保 、住房公积金、带薪年假、五天工作制等基本福利外，更为员工创建人性化的管理环境及出国培训等福利，为个人发展提供顺畅的职业通道。我们将为您提供一个能充分体现个人价值的发展平台！
Forefront的核心价值观是以卓越的工程设计和反应能力来满足客户的需求。并且强调了在保证高品质的同时也适当而有效地不断改善，我们尊敬和珍视每一个客户和雇员。