SENIOR QUALITY ENGINEER
Lotus Technical Services is a leading solutions provider offering a complete range of automation and technical services specifically designed to enhance productivity and efficiency, and to maximise the value of our customer's core business. We are currently recruiting a Senior Quality Engineer for a role based in Limerick.
· 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.
· Use appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)
· Proven track record of implementing projects
· Use Lean Manufacturing, Six Sigma, or similar analysis tools
· Identify and implement improvements within a high volume, fully automated manufacturing environment.
· Review and critique Quality Critical technical documents
· The successful candidate will be Degree qualified in a relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc) with a minimum of 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.
· Six Sigma Certified
· Experience in performing DOE and FMEA
· Experience of the design and qualification documentation standards to current FDA expectations
· Knowledge of statistical packages and Microsoft Office systems required
· A good understanding and working knowledge of FDA and ISO regulations
· Five years experience as Quality Engineer working in a cGMP environment preferably in medical device
Lotus Technical Services is an Equal Opportunities Employer