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Quality Engineer

  • Location: Galway, County Galway, Connaught, Ireland
  • Job Type:Permanent
  • Sector: Engineering
  • Contact: Rhys Joyce
  • Job Ref: 17619

A global leader in Medical Device Manufacturing is looking to hire a Quality Engineer to their growing team in Galway City.


Key Responsibilities

  • Act as a technical resource within the Mechanical Test lab for review, approval, and resolution of non-conformities.

  • Acts as a team member in supporting quality decisions, and practices.

  • Ensures that New equipment validations are carried out in compliance with site/corporate policies and SOPs.

  • Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.

  • Understands and complies with all the regulations governing the quality systems.

  • Evaluates new equipment to support testing for IC, PI and Endo Divisions.

  • Supports new product testing and equipment transfer into the Galway lab.

  • Creates, Reviews and approves new documentation, including test methods, work instructions and validation documents.

  •  Ensures that Calibration and Maintenance for existing and new equipment are fully compliant with site/corporate policies and SOPs.

  • Initiate Equipment Risk Assessments along with associated documentation for equipment and systems.

  • Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.

  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

  • Lead and/or support continuous improvement projects, CAPA and LEAN initiatives.

Qualifications/Requirements

  • 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.

  • Must be an effective communicator to effectively communicate timelines and changes in project milestones.

  • Interfaces with lab customers and vendors including Operations, NPD, Sustaining and OEMs.

  • Preferred knowledge an advantage 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.


For confidential discussion and more information on the role please contact Rhys Joyce.

091-706718

rhys.joyce@collinsmcnicholas.ie