Senior Quality Engineer – Limerick

Senior Quality Engineer – Limerick 

Location: Limerick
Hours: Monday – Thursday: 8:00am – 4:30pm | Friday: 8:00am – 3:30pm
Working Model: Fully Onsite

Job Summary

We are seeking an experienced Senior Quality Engineer to join the Quality team within a leading medical device manufacturing environment in Limerick. The successful candidate will provide day-to-day quality support to manufacturing operations while driving continuous improvement initiatives across quality systems and compliance activities. This role requires a strong all-rounder with experience in line support, CAPA, NCR investigations, and validation activities within a regulated medical device environment.

Key Responsibilities

• Provide daily quality engineering support to manufacturing lines and production operations
• Lead and support CAPA (Corrective and Preventive Action) activities including investigations, root cause analysis, and implementation of effective corrective actions
• Manage and investigate NCRs (Non-Conformance Reports) ensuring timely closure and compliance with quality standards
• Support validation activities including process validation, equipment validation, and documentation review
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• MS office and CAD advantageous 
• Collaborate cross-functionally with Manufacturing, Engineering, and Operations teams to resolve quality issues
• Ensure compliance with FDA, ISO 13485, GMP, and internal quality system requirements
• Participate in continuous improvement initiatives and drive quality improvements across the business
• Support internal and external audits as required
• Review and approve quality documentation, procedures, and reports
• Provide guidance and mentorship to junior team members where required

Requirements

• Degree qualification in Engineering, Science, Quality, or a related discipline
• Minimum 5+ years’ experience in a Quality Engineering role within the medical device or regulated manufacturing industry
• Strong experience in:
  • Manufacturing line support
  • CAPA management
  • NCR investigations
  • Validation activities
• Good understanding of FDA, ISO 13485, GMP, and quality system regulations
• Excellent problem-solving and root cause analysis skills
• Strong communication and stakeholder management abilities
• Ability to work independently and manage multiple priorities in a fast-paced environment
• Experience working in a high-volume medical device manufacturing environment
• Knowledge of statistical analysis and quality tools
• audit experience would be an advantage

For More Info on this excellent job opportunity contact Gary Keane:
Call: 086-1030418
Email: [email protected]

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