Quality Engineer – Medical Devices & Continuous Improvement

CREGG; Munster; On-site; Confidential; 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

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