Overview
Quality Engineer Jobs in Limerick, County Limerick, Ireland at CREGG
Title: Quality Engineer
Company: CREGG
Location: Limerick, County Limerick, Ireland
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 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
For More Info on this excellent job opportunity contact Gary Keane:
Call: 086-1030418
Email: [email protected]
