常州招聘

JOB OVERVIEW:
Development and implementation of quality management system taking consideration of existing group QMS as well as CFDA local requirements.
Obtain ISO 9001 / ISO 13485 / ISO 14001 accreditation.
Responsible for the maintenance and development of quality system in conjunction with the Regulatory Affairs Director, and ensuring that all products are manufactured to the appropriate quality.

RESPONSIBILITIES:
1.To develop and implement quality management system, with consideration to existing group QMS as well as CFDA local requirements.
2.Obtain ISO 9001 / ISO 13485 / ISO 14001 accreditation in order of priority.
3.Set-up quality lab and necessary equipment.
4.Attend training at site 2 / 3 to fully understand products and processes associated with the subsequent product lines to be introduced into site 4.
5.In liaison with the Regulatory Affairs Director, to ensure that Quality System complies with the ISO9001, ISO13845, EEC Directive 93/42, and FDA CFR 21 Part 820.
6.Ensure all factory staff understand Quality requirements, and the Quality Policy.
7.Ensure activities meet with, and integrate with, company requirements for quality management, legal stipulations, environmental policies and general duty of care.
8.Maintenance of the documented quality system, to achieve efficient recording, storage, sharing and retrieval of information.
9.Liaising with quality staff or any other staff to resolve quality issues.
10.To carry out internal audits, and manage the internal audit schedule.
11.To be prepared at any time for external audits.
12.Inspection, gauging and testing of products.
13.Replying to product complaints; implementing corrective and preventive actions; chairing the quarterly CAPA meeting for Site 4; and performing analysis and trending of CAPA data including product complaints.
14.By attending regular meetings held by the Factory Manager and Technical Manager, to suggest or aid in making process improvements.
15.Risk analysis and safety approval of finished products.
16.To carry out annual calibration.
17.To carry out periodic sub-contractor reviews with the Factory Manager.
18.To ensure component quality is acceptable following mould repairs, and recorded on IQR26.

英特赛克医疗器械（常州）有限公司是英国INTERSURGICAL医疗集团旗下在中国设立的全资子公司，主要负责在中国进行采购及销售业务。总公司英国INTERSURGICAL医疗集团公司成立于1985年，专注于一次性呼吸麻醉类医疗用品的生产及销售，公司已通过ISO9001：2000质量管理体系，ISO13485: 2008医疗器械质量管理体系及ISO14001环境管理体系。经过30年的发展，公司现在已成为在呼吸麻醉耗材行业中的领导者，并已经分别在美国，英国，德国，法国，意大利，西班牙，荷兰，捷克，立陶宛，俄罗斯，南非，日本，菲律宾等国家设立了直属的分公司，是一家实力雄厚的跨国企业。公司目前在全球已经拥有超过2000名员工，营业额已超过1.5亿欧元。
    随着中国经济近年来的强劲增长及人民生活水平的显著提高，广大患者对于高品质的一次性医疗耗材的需求也日渐强烈。公司所生产的高端一次性呼吸麻醉类产品已于2008年进入中国市场，为更好的服务于中国市场的广大患者，现诚聘所述人员。

网址：http://www.intersurgical.com.cn