Quality Engineer

1. Assist in maintaining and implementing the Quality Management System (QMS) in compliance with ISO 13485 and company quality policies.

2. Support the maintenance, revision, control, and continuous improvement of ISO 13485 quality system documentation, including procedures, work instructions, forms, and records.

3. Collect, consolidate, and analyze quality-related data, such as nonconformities, CAPA effectiveness, customer complaints, quality KPIs, and process performance metrics. Prepare regular reports and provide recommendations for improvement.

4. Support internal audits, external audits, customer audits, and certification audits, including preparation, execution, and follow-up activities.

5. Assist in the investigation of quality issues and nonconformities, including root cause analysis and the implementation and verification of Corrective and Preventive Actions (CAPA).

6. Support complaint handling processes and assist in monitoring the effectiveness of corrective actions.

7. Collaborate with cross-functional teams to drive quality improvement initiatives and ensure compliance with regulatory and quality requirements.

8. Maintain and control quality records, databases, and documentation to ensure accuracy, completeness, and traceability.

9. Monitor and track quality objectives and key performance indicators (KPIs), providing regular updates and trend analysis to management.

10. Support training activities related to the Quality Management System and maintain training records as required by ISO 13485.

11. Assist in the implementation and maintenance of document control and change control processes.

12. Perform other duties and projects as assigned by the QA Manager.