Quality Engineer

CREGG; Munster; On-site; EUR 55,000 - 75,000; Full time

Job summary

CREGG is seeking an experienced Quality Engineer to join its Quality team in a leading medical device manufacturing environment in Limerick. The role provides day-to-day quality support to manufacturing operations while driving continuous improvement across quality systems and compliance activities.

You will manage CAPA, NCR investigations, and validation activities within a regulated medical device setting, collaborating with Manufacturing, Engineering and Operations to optimise processes and

Qualifications

• Degree in Engineering, Science, Quality or related discipline.
• 4+ years in a Quality Engineering role within medical device or regulated manufacturing.
• Experience in manufacturing line support, CAPA, NCR investigations, and validation activities.
• Good understanding of FDA, ISO 13485, GMP and quality systems.

Responsibilities

• Provide daily quality engineering support to manufacturing lines and production operations.
• Lead CAPA activities including investigations, root cause analysis and corrective actions.
• Manage and investigate NCRs ensuring timely closure and compliance.
• Support validation activities including process and equipment validation and documentation review.
• Identify opportunities to optimise manufacturing processes using Six Sigma/LEAN methods.
• Collaborate with Manufacturing, Engineering and Operations to resolve quality issues.
• Ensure compliance with FDA, ISO 13485, GMP and internal quality system requirements.
• Participate in continuous improvement initiatives and audits.
• Review and approve quality documentation, procedures and reports.
• Provide guidance to junior team members.

Skills

Quality engineering

CAPA management

NCR investigations

Validation activities

Root cause analysis

Stakeholder management

Lean Six Sigma

Problem solving

Education

Engineering degree

Science degree

Quality qualification

Tools

CAD

MS Office

Job description

We are seeking an experienced 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 4+ 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
• auditexperience would be an advantage

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