深圳招聘

职位描述：

Responsibilities: ？

1、 Establishing and maintaining quality management system with compliance with ISO13485 21CFR820 ？

2、Handling customer audit and lead the team to take actions for any NCs to meet customer’s

requirements. ？

3、Support routine Quality department functions, including product quality review, calibration and

validation programs, line clearance, product returns, complaints and recalls. ？

4、Provide support for the implementation of Good Manufacturing Practices standards ？

5、Be a mentor/coacher to training internal employee on all aspects of quality management.

General Requirements: ？

1、B.S. or above in Engineering/Science or management ？

2、Minimum 5 years of working on quality dept. at least 2 years’ experiences on quality management

position. ？

3、Experienced in OQA and knowledgeable in international standards such as ISO9000, ISO14001, ISO13485. ？

4、Strong analytical skills with attention to detail, experience and sense of problem solving knowledge;

5、Auditing, inspection techniques & supervisory skills ？

6、Good knowledge in Quality tools (FMEA & Control Plan, APQP, SPC, PPAP, MSA, 8D, 5-Why analysis) ？

7、Good knowledge in ESD and industrial standard ？

8、Proactive individual who can work under high pressure and drive internally to meet deadline. ？

9、Excellent written English and good command in spoken English.

Nice To Have Requirements: ？

1、Knowledge on QSR820/21CFR820, FDA audit. ？

2、Experience on lean production, and knowledge on six sigma.

Location: ShenZhen,

China About company: B&J Manufacturing Ltd. is a medical biomaterials manufacturing for the

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深圳市斯佳电器有限公司专注于医疗器械、微型电机和定时器的生产销售，产品包括静脉血栓治疗仪、医疗护具、交流同步电机、直流减速电机、直流变频同步电机、无刷直流电机、定时器。服务于各类家用电器及医疗保健器械制造商。

植入ISO9001、ISO13485及QSR820管理模式，精心设计和制造，优良的产品品质和服务赢得众多知名家用电器及医疗保健器械企业的认可与支持。DUNS编码及美国FDA认证（FDA注册号：10042861）是我们质量和信用的证明。我们的产品有幸成为艾美特(Airmate)、美的(Midea)、虎牌(Tiger)、象印(ZOJIRUSHI)、惠而浦(Whirlpool)等世界级品牌的核心部件。

我们一直密切关注市场和客户的需求，快速反应配合客户，包括产品的质量控制、新品开发、成本管制，快捷的交货能力也常为客人称道。