Quality TechnicianLocation: GalwayDepartment: Quality AssuranceReporting To: Senior Quality EngineerA leading medical device manufacturer is currently seeking a Quality Technician to join its operations support team in Galway. This is an excellent opportunity for a detail-oriented individual to contribute to the ongoing success and compliance of a high-quality manufacturing environment.Key Responsibilities:

• Ensure compliance with all applicable regulatory standards and current Good Manufacturing Practices (GMP).
• Conduct product defect analysis.
• Perform routine final functional testing, product release criteria testing/inspection, and accurately record test results.
• Review and approve finished device labels.
• Prepare and ship bioburden samples.
• Review and update Quality Assurance documentation.
• Control non-conforming products and maintain related records.
• Identify and report any quality issues or deviations from standard processes or procedures.
• Participate in problem-solving and continuous improvement investigations.
• Conduct incoming inspection of materials.
• Support and maintain document and record control processes.
• Provide assistance to the Quality Engineering and Operations teams.
• Support operator training initiatives.
• Communicate any concerns about environmental impact, health, or safety issues to the relevant manager.
• Actively contribute to corrective and preventive action (CAPA) processes.
• Support and participate in continuous process improvement initiatives.
• Escalate any potential issues to ensure timely resolution.Education & Experience Requirements:
• Diploma in Quality or a related discipline, or significant relevant experience in a quality assurance role within the medical device industry.
• 1–2 years of experience in a medical device manufacturing environment operating under GMP.
• Working knowledge of medical device regulatory requirements such as ISO 13485 and FDA QSR 21 CFR Part 820.
• Familiarity with Quality Management Systems.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint).
• Strong attention to detail with excellent documentation skills.
• Ability to work independently and collaboratively within a cross-functional team.
• Basic understanding of statistical techniques.
• Excellent verbal and written communication skills.
• Self-motivated and capable of influencing positive change.