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