苏州招聘

Basic skills：
Excellent logical thinking
Good communication skills and training skills.
Good operation skills of MS-Office
CET4 or above, excellent in written and listening English, able to communicate in oral English
over 5 years experience as Quality system engineer in manufacturing plant
at least 2 years’ Experience in GMP or ISO13485 medical quality system
ISO13485 internal auditor certificate is must
Bachelor or above degree in science and engineering


Responsibility：
To introduce ISO13485 quality system and ensure it meet FDA requirement
Be familiar with FDA requirements & ROHS 2.0 standard
Be familiar with ISO13485 related laws and regulations of China, EU and FDA必须要有导ISO13485 医疗器械质量管理体系的经验！

Be familiar with 8D skills, QC 7 tools and MSA, control plan and FMEA
Responsible for developing, applying, revising, and maintaining quality standards/procedures/control plan/FMEA to support manufacturing activities.
Making sure the GMP and ISO13485 requirements are implemented correctly and followed strictly.
To lead internal and external audit for ISO13485 & 9001 and action plan driving for the NCR, follow up the effectiveness of the actions
Lead regular internal audit to quality system and push continual improvement
Support manager to organize management review
Other task assigned by QA manager

LELO China是瑞典LELOi AB在中国投资的全资子公司，旗下设有三家分支机构，其中上海公司，是LELO全球的研发设计、PR、销售中心；苏州公司为全球生产制造中心；深圳设有办事处。

本公司主要生产手握式按摩器、高品质情趣用品及相关附属产品；产品在全球40多个国家和地区均有销售。

优秀的人才始终是推动公司不断发展的原动力。我们尊重知识、尊重人才，强调专业技能和素质的持续学习与进步，提升员工自身价值，并为表现优秀的员工提供职业发展规划。

如您渴望进入新兴朝阳行业，谋求长远职业发展，我们期待您的加入，携手共进，共享机遇与挑战！

我们为您提供有竞争力的薪酬、完善的福利和培训体系以及良好的个人发展空间和优雅的工作环境，为优秀人才创造机会，使其充分施展才华，发挥最大潜能。我们秉承以人为本的用人方针，诚挚邀请您一起携手并进，共创美好未来！

LELO苏州
苏州翰墨科技有限公司
地址：江苏省苏州工业园区苏虹中路77号
电话：+86 512 62588561
邮编：215027

上海莱珞贸易有限公司
地址：上海市徐汇区乌鲁木齐南路396弄10号国邦花园大厦701-706
电话：+86 21 54041891/54032786
邮编：200031

网址：www.lelo.com