Title: Manufacturing Technician
Location: Galway
Benefits: Salary, bonus, pension and healthcare


Overview:
As a Manufacturing Technician you will support day-to-day production by maintaining efficient and compliant operations on the manufacturing line. Key responsibilities include troubleshooting issues, performing equipment setups and maintenance, supporting process improvements, and ensuring accurate documentation in line with GMP and quality standards.


The Manufacturing Technician will work as part of a team to assist in the manufacture of innovative medical devices in accordance with the requirements of International Standards: ISO 13485, FDA 21 CFR Part 820, EU Medical Device Regulation (MDR) and the Vivasure Medical Quality Management System



Responsibilities:

• Respond promptly and effectively to manufacturing line stoppages or anomalies to minimise production downtime.
• Provide day-to-day technical support to the manufacturing line to ensure consistent and efficient operations
• Troubleshoot and resolve issues related to equipment, tooling, process, or material.
• Perform manufacturing line set-ups and operate equipment, ensuring proper use and functionality.
• Carry out routine and preventative maintenance on production equipment.
• Identify and implement improvements to manufacturing processes, tools, jigs, and methods that enhance product quality, efficiency, and manufacturability.
• Support the elimination of waste and inefficiencies using Lean, Six Sigma, or other continuous improvement methodologies.
• Participate in process development activities for new and existing products.
• Assist with equipment, process and product verification and validation testing.
• Maintain accurate and complete batch records, logs, check sheets, and maintenance records in compliance with GMP and quality system requirements.
• Conduct or support in-process inspection, functional testing, and non-conformance investigations

• 3^rd level qualification in a relevant technical field is advantageous
• Knowledge of quality standards including ISO 13485, MDR, and FDA requirements.
• 1-3 years hands-on experience in Medical device / pharma industry