Quality Technician

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.

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