Reference Code
DU1916

We require a Senior Quality Engineer for a role based in Limerick

Working within the Quality function, this role will involve identifying and implementing improvements within a high volume, fully automated manufacturing environment.

You will be responsible for analysis, identification and implementation of manufacturing and/or business process improvements which will improve capability and performance.

Prior experience of SPC and statistical analysis tools is essential.

The successful candidates will

  • Have demonstrated experience and implementation of using Lean Manufacturing, Six Sigma, or similar analysis tools
  • Proven track record of implementing projects
  • Use appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)
  • Degree qualified in a relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc) with a minimum of 5-7 years relevant experience
  • Proven track record of implementing Six Sigma and/or Lean Continuous Improvement projects
  • Experience within Medical device industry is desirable but not essential.

Education/Qualifications

  • 5 years’ experience in a regulated environment
  • SIX SIGMA – Certification
  • Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
  • Experience of the design and qualification documentation standards to current FDA expectations
  • Knowledge of statistical packages and Microsoft Office systems required
  • Proven ability to review and critique Quality Critical technical documents
  • A good understanding and working knowledge of FDA and ISO regulations
  • Knowledge of lean manufacturing
  • Five years’ experience as Quality Engineer working in a cGMP environment preferably in medical device
  • Self-Motivated - requires minimal direct supervision.
  • Must have good written and presentation skills and be able to communicate effectively throughout organization
  • Demonstrated Experience working with data base applications desired
  • Ability to set priorities while ensuring compliance is not compromised
  • Experience in performing Design of Experiments (DOE) and leading

 
















































 

 


 

 


 

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

Submit an Application Now

Do you have what it takes ?

Senior Quality Engineer DU1916 - DU1916

Limerick, Ireland

Accepted formats are: Microsoft® Word and PDF files
Maximum 200 words allowed.