Quality Engineer

CREGG; Limerick; On-site; EUR 60,000 - 75,000; Full time

Job summary

CREGG is seeking an experienced Quality Engineer to join our quality team in Limerick, Ireland. You will support manufacturing operations, drive continuous improvement, and ensure compliance with medical device quality systems.

In this role you will lead CAPA and NCR investigations, manage risk documentation and validation activities, and collaborate with cross-functional teams to optimize processes while adhering to FDA/ISO 13485 and GMP standards.

Qualifications

• 4+ years of quality engineering experience in medical device manufacturing.
• Experience with CAPA, NCRs, risk management and validation activities.
• Knowledge of FDA/ISO 13485 and GMP regulatory requirements.
• Strong problem-solving, communication and stakeholder management.

Responsibilities

• Provide daily quality engineering support to manufacturing lines.
• Lead and support CAPA activities including investigations and root-cause analysis.
• Manage NCR investigations and ensure timely closure.
• Support validation activities including process and equipment validation.
• Collaborate across Manufacturing, Engineering and Operations to improve processes.
• Review and approve quality documentation and reports.
• Participate in audits and ensure compliance with quality systems.

Skills

CAPA management

NCR investigations

Risk management

Process validation

Six Sigma

LEAN

Root cause analysis

Quality engineering

Education

Engineering degree

Science degree

Quality discipline

Tools

MS Office

CAD

Job description

Hours: Monday – Thursday: 8:00am – 4:30pm | Friday: 8:00am – 3:30pm

Working Model: Fully Onsite

Job Summary

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
• experience in Risk management documentation, PFMEAs, Test methos validations, TMVs, product release testing and regulatory documentation, product tranfer activities, project management.
• 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:
• Experience in Risk management documentation, PFMEAs, Test methos validations, TMVs, product release testing and regulatory documentation
• 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