We are seeking a highly skilled Quality Specialist to join our team in a rapidly growing organization. This role will play a pivotal part in ensuring the quality and compliance of our manufacturing processes, contributing to the delivery of life-changing medical devices.
Key Responsibilities:
* Ensure adherence to all applicable regulatory standards and current Good Manufacturing Practices (GMP) procedures and protocols.
* Perform thorough product defect analysis to identify areas for improvement.
* Routine final functional testing, product release criteria testing/inspection, and recording of test results.
* Review and approval of finished device labels to ensure accuracy and compliance.
* Preparation and shipment of bioburden samples to support quality control measures.
* Review and update of Quality Assurance documentation to ensure it remains relevant and effective.
* Control of non-conforming product to minimize waste and maintain quality standards.
* Identify and report any quality issues or deviations from process/procedures to ensure timely resolution.
* Conduct problem-solving and continuous improvement investigations to drive quality excellence.
* Perform incoming inspection of materials to ensure they meet quality and safety standards.
* Support and maintain document and record control processes to ensure accuracy and accessibility.
* Provide assistance and support to the Quality Engineering and Operations functions to ensure seamless collaboration.
* Support operator training to enhance knowledge and skills.
* Communicate any concerns about work processes regarding environmental impact, health, or safety issues to management.
* Actively participate in the initiation and implementation of Corrections, Corrective, and Preventive actions to drive quality improvements.
* Actively participate in continuous process improvement initiatives to drive business growth and excellence.
Required Skills and Qualifications:
* Degree in Quality or a related field 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 (GMP).
* Knowledge of medical device regulatory requirements, including ISO13485 and FDA QSR 21CFR Part 820.
* Knowledge of and adherence to Quality systems to ensure compliance and excellence.
* Good computer skills in using MS Office Suite - Microsoft Word / Excel / PowerPoint.
* Ability to work independently and collaborate in a cross-functional teamwork environment.
* Strong written and verbal communication skills are essential for effective collaboration.
* Motivated individual capable of influencing change and driving quality excellence.