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 & 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 please contact Emma Barry.
emma.barry@collinsmcnicholas.ie
091 706719