Our client a rapidly growing organisation based in Oranmore Co Galway are looking to hire a Quality Technician as they expand operations.
The Role:
As the Quality Technician you will play a pivotal role in ensuring the quality and compliance of our manufacturing processes, contributing to the delivery of medical devices that change lives.
Responsibilities:
* Ensure compliance to all applicable regulatory standards and current GMP procedures and practices.
* Perform product defect analysis.
* Routine final functional testing, product release criteria testing/inspection and recording of test results.
* Review and approval of finished device labels.
* Preparation and shipment of bioburden samples.
* Review and update of QA documentation.
* Control of non-conforming product.
* Identifying and reporting any quality issues or deviations from process/procedures.
* Problem solving and continuous improvement investigations.
* Perform incoming inspection of materials.
* Support/maintain the document and record control processes.
* Provide assistance and support to the Quality Engineering and Operations function.
* Support operator training.
* Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager.
* Actively participate in the initiation and implementation of Corrections, Corrective and Preventive actions.
* Actively participate in continuous process improvement initiatives.
* Escalate potential deficiencies to ensure timely resolution.
Requirements:
* Diploma qualification in Quality or a related discipline or significant relevant experience in a quality assurance role within the medical device industry.
* At least 2 years’ experience working in a medical device manufacturing environment complying with Good Manufacturing Practices.
* Knowledge of medical device regulatory requirements (e.g. ISO13485, FDA QSR 21CFR Part
* 820).
* Knowledge of and adherence to Quality systems.
* Good computer skills in using MS Office Suite - Microsoft Word / Excel / PowerPoint.
* Ability to work on own initiative and collaborate in a cross-functional teamwork environment.
* Good documentation skills with strict attention to detail.
* Basic understanding of statistical techniques.
* Strong written and verbal communication skills are essential.
* Motivated individual and capable of influencing change.
For more information and a confidential discussion on the role of Quality Technician, please contactMichelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717
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