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 *****, 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 *****, 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
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