南京招聘

Job scope:

1.Creation and development of technical documentation as well as the management and control of a corporate Quality documentation system, including the documents, records and associated processes.

建立并发展质量体系文件及技术文档,包括各相关过程的文档和记录

2.Review and distribute the new/revised document as per document change request.

审核并分发文件变更记录所要求的新文件或修改的文件

3.Establishes and maintains a central repository, including history files, for all controlled Quality & Regulatory documents and records.

建立并维护中心文档,包括质量及法规的所有文档记录

4.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.

承担实施及维护法规体系文件的职责,包括根据ISO/QSR要求新建和更新程序文件

5.Ensure the consistency and quality system of Medical Device product, process, and policy documentation.

确保质量体系的产品,过程,程序文件一致性

6.Clean room monitoring monthly and data analysis.

洁净室月度监控和数据分析

7.Follow up the internal audit and external audit findings to ensure the closure timely.

跟进内审/外审的发现,确保及时关闭

8.Responsible for NEO Induction Training.

负责入职培训(质量部分)

9.In-charge of review the DHR and batch record.

负责评审DHR及批记录

10 Support QA Dept. for the daily grind, including office supply requisition and checking attendance each month by system.

支持QA部门的日常事务,包含日用品的采购,检查每月的出勤

11.Review of Sterilization report and certificate; Issue COC for outgoing goods.

审核灭菌报告,完成成品出货COC

12.Supervise and coordinate with Micro lab technician for Micro lab daily operations.

管理并协助微生物技术员负责微生物实验室的日常运行

job requirement:

1. Degree or diploma 大学或大专以上学历

2. At least 2 year experience in Micro lab as lab technician or supervisor. 至少有两年以上微生物实验技术员或主管经验。

3. Major in Pharmacy, Pharmaceutical Engineering or Microbiology 制药 / 制药工程 / 微生物学专业

                                   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。