Overview
Quality Engineer Jobs in County Galway, Ireland at Sterling Engineering Ltd – Ireland & Europe
Title: Quality Engineer
Company: Sterling Engineering Ltd – Ireland & Europe
Location: County Galway, Ireland
Quality Engineer II
*4 day working week based outside of Galway City
Overview
We are seeking a detail-oriented Quality Engineer II to ensure compliance with regulatory requirements, drive improvement, and maintain high-quality manufacturing standards.
Key Responsibilities
Identify and document customer requirements for manufacturing.
Maintain a compliant Quality System.
Develop and review inspection plans.
Investigate and resolve quality issues and customer complaints using CAPA.
Assess and approve product and manufacturing changes.
Ensure process validation aligns with requirements; write protocols and reports.
Lead quality and supplier audits, and support regulatory audits.
Document and approve manufacturing procedures and inspection standards.
Use process data to drive continuous improvement.
Supervise and support assigned staff.
Collaborate with customers and suppliers on quality matters.
Ensure adherence to safety and environmental requirements.
Support improvement in OH&S, Environmental, and Energy Management systems.
Perform additional duties as assigned.
Qualifications & Skills
Degree/diploma in Engineering, Science, or Quality, or equivalent experience in Medical Device Industry.
5+ years’ experience in a similar manufacturing environment.
Strong leadership and team management skills.
Excellent attention to detail and problem-solving.
Knowledge of regulatory requirements (ISO 13485, FDA, etc.).
Six Sigma Green Belt required; Lean Green Belt is a plus.
Understanding of lean manufacturing.
