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Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Senior Quality Engineer


Reference:JOM ALKI-545522 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Engineer

Reference JOM ALKI-545522

Senior Quality Engineer

Location: Dun Laoghaire, Dublin

Main Responsibilities:

  • Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
  • Contributes to the completion of specific programs and projects
  • Independently determines and develops approach to solution
  • Liaise with Manufacturing Plants and provide support to cross-functional teams
  • Define product control strategy, lead risk management activities and ensure design control elements are satisfied. Ensure/ perform process validation activities
  • Support supplier qualification activities – risk classification assessment and product quality assessments
  • Evaluate test methods used in project activities
  • Evaluation of customer requirements to identify applicable quality standards
  • Release product (customer samples) during development activities and realization of quality functional reviews
  • Ensure implementation of Pharmaceutical Systems global procedures and standards for QE engineering activities
  • Provide support to internal, regulatory body and customer audits and associated corrective actions.
  • Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share

Experience:
  • Minimum of 5 years of relevant experience (Medical Device/ Pharmaceutical)
  • BS degree in Engineering, or other scientific discipline.
  • Knowledge of design control principles.
  • Good understanding of statistical methods for Quality Assurance
  • Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
  • Good written and oral communication skills
  • Ability to handle multiple projects simultaneously in an unsupervised environment.
  • Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project
Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role.


Contact Joan O’Malley at 087-1897333 for more details.