宜昌 [切换城市] 宜昌招聘宜昌质量管理/安全防护招聘宜昌质量管理/测试工程师(QA/QC工程师)招聘

(Sr.)Design Quality Engineer

美敦力中国

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2017-11-27
  • 工作地点:上海
  • 工作经验:无工作经验
  • 学历要求:本科
  • 职位类别:质量管理/测试工程师(QA/QC工程师)  

职位描述

职位描述:
MAIN JOB DUTIES/RESPONSIBILITIES (Please list most important duties first)

? Design Control
? Provide oversight of design activities to ensure compliance to MDT China Design Control procedures and corporate requirements
? Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File.
? Working closely with SBU to develop project execution plan, especially focusing on quality strategy and quality plan
? Collaborate with R&D team to develop and solidify Product Development Process to align with global quality, SBU and local requirements.

? Quality Engineering
? Lead team to conduct Risk Control activities: Application Risk, Design Risk and Manufacturing
? Participate in Design Verification and Validation to ensure robust qualification of product and process designs
? Support Process Validation activities and make sure the processes are in compliance with requirements
? Support for DOE (Design of Experiments), sampling plans, capability assessments & root cause analysis
? Product quality verification post launch and coordinate evaluation and disposition to the Nonconformance products from OEM/CM

? Supplier Quality Control
? Collaborate with sourcing and engineering team on supplier/vendor selection and evaluation.
? Lead qualification of suppliers and development of quality agreement and supplier control plans
? Monitor contract manufacturer or OEM product quality control post product launch

? Routine Operation
? Assisting in the development and continuous improvement of Quality Systems for China R&D in alignment with regional and corporate requirements. Support quality routine operation,
? Other tasks assigned by line manager


JOB QUALIFICATIONS
1. Working experience of quality or R&D in medical device/pharm/similar industry is not less than 5 years
2. Familiar with ISO13485, GMP on medical device
3. Familiar with design process, project flow & control, risk assessment & management, process validation & verification , statistics & sampling plan etc.
4. Good documentation practice & quality sense
5. Good communication and negotiation skill with project team, Good quality influence power
6. Good written and oral English
7. Working in Global company / familiar with IT technology/ Professional Trainer is prefer

职能类别: 质量管理/测试工程师(QA/QC工程师)

关键字: 医疗器械 质量工程师

公司介绍

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.

联系方式

  • 公司地址:北京