Quality Assurance Executive

Job Description

1. Conduct regular inspections of raw materials and components to ensure they meet required specifications before production begins. 2. Perform in-process checks and final product testing to ensure the finished blood collection tubes meet established standards for quality, safety, and performance. 3. Verify product labeling, packaging, and batch documentation for compliance with regulatory guidelines. 4. Ensure adherence to international regulatory standards such as ISO 13485, FDA regulations, and CE Marking requirements for medical devices. 5. Monitor and ensure compliance Prepare and submit required quality assurance documentation for regulatory audits and inspections. 7. Monitor production processes to identify potential quality issues, non-conformances, or deviations from established standards. 8. Lead root cause analysis investigations for quality issues and implement corrective and preventive actions (CAPA). 9. Work closely with the production team to optimize processes and ensure high-quality production output. 10. Conduct internal audits to assess the effectiveness of the Quality Management System (QMS) and ensure all documentation is compliant. 11. Oversee the handling of customer complaints and non-conformance reports (NCRs), ensuring timely resolution and feedback. 12. Maintain accurate and detailed records of quality control tests, inspections, audits, and corrective actions. 13. Ensure all quality assurance documents are up-to-date, accessible, and compliant with company policy and regulatory requirements. 14. Prepare quality reports and summary data for management review. 15. Provide quality-related training to production staff, emphasizing the importance of quality control and compliance with regulations. 16. Manage communications with customers regarding quality issues, ensuring that customer requirements are met and feedback is effectively incorporated into product improvements. 17. Identify, investigate, and manage non-conformities within the production process, working with cross-functional teams to address the root causes.