Job Description
Quality Engineering Manager - NPI: South Dublin
Ref No: AM18358
Leading critical projects for new product introduction at the plant involves providing leadership to a team, managing validation studies, and collaborating with internal and external stakeholders.
Key Responsibilities:
• Support quality management systems aligning with international standards.
• Ensure regulatory compliance with company and external requirements.
• Lead the Quality Engineering Team through daily management, performance reviews, and delegation.
• Support programs like Six Sigma to enhance processes and product quality.
• Oversee production support systems, such as non-conformance and customer complaint analysis.
• Liaise with key external customers to ensure quality standards meet expectations.
• Ensure Corrective and Preventive Actions are completed in compliance with regulatory standards.
• Ensure Good Manufacturing Practice compliance in Production and Quality Engineering activities.
• Prepare and maintain documentation to meet regulatory requirements.
Education & Experience Requirements
• At least 5 years of industry experience in an ISO environment, preferably in medical devices or pharmaceuticals.
• A minimum of 3 years of supervisory experience, indicating the need for leadership skills.
• Understanding of Statistical Process Control and Six Sigma methodologies, with Greenbelt Certification advantageous. Advanced Technical writing skills required.
• Experience with FDA requirements and audits
• Experience in process validation, sterilization, and cleanroom environments is beneficial.