HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Mark Wilson
email talent@hero.ie

Quality Engineer- Equipment

Apply Now

Job ID: JOB-11909
Quality Engineer- Equipment

Our client, a global leader in Medical Devices are looking to attract a Quality Engineer to join their team in Galway. This role is commutable from Mayo, Limerick & Clare.

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. 

Key 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 further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Mark Wilson

JOB-11909

Apply Now

Quality Engineer- Equipment

Mark Wilson

Role Type Permanent
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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