东莞 [切换城市] 东莞招聘

Compliance Engineer

深圳市惠恩管理咨询有限公司

  • 公司规模:少于50人
  • 公司性质:民营公司
  • 公司行业:外包服务

职位信息

  • 发布日期:2020-11-04
  • 工作地点:深圳
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:大专
  • 语言要求:英语熟练
  • 职位月薪:20-30万/年
  • 职位类别:认证工程师

职位描述

Job Responsibilities:

  •  Review test reports for completeness and accuracy of data /results and company info.
  • Follow up certification status on critical components supplier such as adapter to generate a proper salable list for products.
  • Work with factory to prepare compliance documents, and to resolve compliance failures with lab and factory, to ensure no impact product ETD.
  • Researching and identifying applicable regulatory and compliance standards .
  • Maintain documentations in drop box for certifications, test reports, RoHS, Prop 65, REACH, FDA DHF.
  • Establish and maintain labeling control procedure for the affected countries,to ensure fulfillment of product labeling requirements.
  • Maintain DHF (hard copy and E-copy) for each medical device so that to compliance FDA CFR 820.30 requirements.
  • Perform regular audits to China manufacturers to verify compliance of products in aspects of safety /chemicals (RoHS, Prop 65 and REACH) and FDA CFR 820.
  • Work with compliance manager to develop compliance strategies to reduce costs and lead-time to markets


Requirement:

-Bachelor’s degree in Electrical or Mechanical Engineering.

-10 years consumer electronics product compliance experience, home appliance products or beauty care products experience preferred.

-10 years' experience managing regulatory compliance submissions.

-Experience with and understanding of domestic and international requirements including UL, IEC, kc, GS,CE etc. 

- Know well about  ISO 13485:2016, FDA Quality System Regulation, MDR knowledge preferred

- Excellent multitasking and time management skills

- Good English in reading and writing, good speaking is a plus. 

职能类别:认证工程师

公司介绍

Ethical
This is HAL’s foundation. Without it, HAL can not go further. We are straight forward with both our clients and candidates. We do not play games for commercial benefits.
Persevere
For various reasons, the assignment might experience a tough time and become very challenging. We keep our enthusiasm. We know there is a turning point if we work hard and smart.
Professioal
We keep on learning and speak inside languages. We evaluate candidates objectively and provide high quality recommendation report. We keep confidentiality.
Sharing
We work as a team, sharing our happiness, frustrations, resources, and knowledge. We share our profit.
Efficient
Our average time frame to identify 3 suitable candidates is between 1 to 3 weeks. This efficiency is based on our wide personal network, our database, our information collection skill and our result-oriented spirit.
Work For Fun
Work is an important part of our life. We enjoy from it. We absorb knowledge everyday from our work and we toast for every progress.

联系方式

  • 公司地址:地址:span深圳市