Direct message the job poster from Sterling Engineering Ltd - Ireland & Europe
Senior Consultant - Sterling Engineering
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance, Production, and Engineering
Industries
Medical Equipment Manufacturing
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