Job Title
We are seeking a Quality Assurance Specialist to join our team in ensuring the quality and compliance of our manufacturing processes.
The successful candidate will play a pivotal role in maintaining the highest standards of quality, safety, and regulatory compliance across all aspects of our operations.
1. Ensure adherence to all applicable regulatory standards and current Good Manufacturing Practices (GMP).
2. Perform product defect analysis, including investigation, root cause identification, and corrective action implementation.
3. Routine final functional testing, product release criteria testing/inspection, and recording of test results.
4. Review and approval of finished device labels.
5. Preparation and shipment of bioburden samples.
6. Review and update of QA documentation.
7. Control of non-conforming product.
8. Identify and report any quality issues or deviations from process/procedures.
9. Investigate and resolve quality-related problems through root cause analysis and corrective action implementation.
10. Conduct incoming inspection of materials.
11. Support and maintain document and record control processes.
12. Provide assistance and support to the Quality Engineering and Operations function.
Requirements:
* Bachelor's degree in a relevant field, such as Quality Assurance or a related discipline.
* At least 2 years' experience working in a medical device manufacturing environment complying with GMP.
* Knowledge of medical device regulatory requirements, including ISO 13485 and FDA QSR 21 CFR Part 820.
* 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 capable of influencing change.