Neurent Medical is seeking a dedicated and detail-oriented Quality Technician to become a member of our Operations support team. The ideal candidate 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.
DUTIES AND RESPONSIBILITIES:
Ensure compliance to all applicable regulatory standards and current GMP procedures and practices.
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.
Education/Experience
Diploma qualification in Quality or a related discipline OR significant relevant experience in a quality assurance role within the medical device industry.
1 - 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.
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.
#J-18808-Ljbffr