Job Description
We are seeking a Quality Assurance Specialist to join our team in Oranmore, Co Galway. As a Quality Technician, you will play a key role in ensuring the quality and compliance of our manufacturing processes.
The successful candidate will have a diploma qualification in Quality or a related discipline, with at least 2 years' experience working in a medical device manufacturing environment complying with Good Manufacturing Practices.
You will be responsible for ensuring compliance to all applicable regulatory standards and current GMP procedures and practices. This includes performing product defect analysis, routine final functional testing, and recording of test results.
Additionally, you will review and approval of finished device labels, prepare and shipment of bioburden samples, and review and update of QA documentation.
As a Quality Assurance Specialist, you will also identify and report any quality issues or deviations from process/procedures, perform incoming inspection of materials, and provide assistance and support to the Quality Engineering and Operations function.
Responsibilities:
* Ensure compliance to all applicable regulatory standards and current GMP procedures and practices.
* Perform product defect analysis, routine final functional testing, and recording of test results.
* Review and approval of finished device labels.
* Prepare and shipment of bioburden samples.
* Review and update of QA documentation.
* Identify and report any quality issues or deviations from process/procedures.
* Perform incoming inspection of materials.
* Provide assistance and support to the Quality Engineering and Operations function.
Requirements
To be considered for this role, you must have a diploma qualification in Quality or a related discipline and at least 2 years' experience working in a medical device manufacturing environment complying with Good Manufacturing Practices.
You must also have knowledge of medical device regulatory requirements, such as ISO13485 and FDA QSR 21CFR Part 820.
Furthermore, you should have good computer skills in using MS Office Suite - Microsoft Word / Excel / PowerPoint, and ability to work on own initiative and collaborate in a cross-functional teamwork environment.
You should also have strong written and verbal communication skills, motivated individual capable of influencing change, and basic understanding of statistical techniques.