Quality Engineer I/II (Mechanical Test Lab)

Job description

About Your New Employer

This is an exciting opportunity to take the next step working with a Medical Device company in Galway that has been ranked as one of the best places to work by countless publications in the past few years. Your job as Quality Engineer I/II (Mechanical Test Lab) will give you the opportunity to see this in action and give you the opportunity to make a difference in people's lives. 


About Your New Job

  • You will act as a technical resource within the Mechanical Test lab for review, approval and resolution of non-conformities.
  • You'll be a team member in supporting quality decisions, and practices.
  • Ensure that new equipment validations are carried out in compliance with site/corporate policies and SOPs, you will demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
  • Understand and comply with all the regulations governing the quality systems.
  • It is your job to evaluate new equipment and to support testing for IC, PI and Endo Divisions.
  • You will support new product testing and equipment transfer into the Galway lab.
  • Create, review and approve new documentation, including test methods, work instructions and validation documents.
  • You will ensure that Calibration and Maintenance for existing and new equipment are fully compliant with site/corporate policies and SOPs.
  • You Initiate Equipment Risk Assessments along with associated documentation for equipment and systems.
  • Evaluate in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Lead and/or support continuous improvement projects, CAPA and LEAN initiatives.


What You Need

  • A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline.
  • 2-3 years experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.
  • Effective communication skills to effectively communicate timelines and changes in project milestones.
  • Interfaces with lab customers and vendors including Operations, NPD, Sustaining and OEMs.
  • Knowledge of Mechanical test methods such as: Leak, Burst, Tensile, Particulate, Lubricity, Tracking, Optical Measurement & Torsion testing
  • Demonstrate a primary commitment to patient safety and product quality.

What's on Offer

In addition to all statutory entitlements and a meaningful job where you help save lives, you will get: 

  • 10% Annual Bonus
  • Fully covered Health Insurance for you and your family
  • Pension Scheme
  • Stock Ownership Programme 
  • Flexitime
  • Paid Maternity Leave
  • Career Progression Opportunities 


Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E:    

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