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Alexa Tralla
Life Science

+353 1 507 9255
alexa.tralla@lifescience.ie
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Details

Quality Engineering - Senior - Contract


Reference:AMII-510415 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Engineering Manager, Quality Engineer

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)
  • Excellent interpersonal and communication skills
  • 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.

Other Skills, Experience and Education

• 5 yrs 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. Desirable
• Knowledge of lean manufacturing
• Five years experience as Quality Engineer working in a cGMP environment preferably in medical device.
• Positive attitude
• Continuous Improvement orientation
• Accepting of change
• Flexible - Calmly reacts to the unexpected .
• Credible – Accountable for decisions
• Self-Motivated – requires minimal direct supervision.
• Results focused – maximizes business benefit from all activities.
• Innovation – thinks laterally but within a compliant framework.
• Organized – Able to cope with extensive documentation and planning requirements.
• Six Sigma or quality engineer certified,
• Structured problem solving and decision making skills working in a team environment.
• Ability to participate in or leading cross functional project teams
• 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

If you would like further information you can contact:



Alexa Tralla | Tel: +353 (0) 1 507 9255


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