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Quality Systems Engineer - Lean Projects

Job description

Responsibilities

  • Identify and implement effective QMS processes to support continuous improvement and lean initiatives onsite
  • You will be directly involved incoming inspection of materials and supplier quality management, overseeing general QA activity
  • Support and deliver continuous improvements and to employ problem solving tools including root cause analysis and CAPA identification. This will also involve taking a lead on the implementation of finding from CAPA and Root Cause Analysis to meet and exceed internal and external requirements
  • Provide training on quality systems and compliance.
  • Work on RA and Compliance requirements and aid in submissions.
  • Conduct internal audits to ISO13485 and GMP requirements, addressing all NCR issues and preventing reoccurrence
  • Be part and take lead role in active improvement of the QMS while ensuring complete compliance to GMP for all devices

 

Requirements

  • Minimum of 2 years experience in a medical device or similarly regulated environment with a science, engineering or equivalent degree
  • Good working knowledge of ISO13485 systems and medical device compliance

  

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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