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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