Responsible for quality control inspections at subcontractor sites and final acceptance testing of finished goods. Oversees production and process control activities, ensuring compliance with ISO 13485, regulatory requirements, and continuous improvement.
Key Responsibilities:
Perform QC inspections of raw materials, in-process, and finished products at subcontractor sites.
Ensure accurate documentation and reporting in compliance with GDP.
Verify and implement ECOs, including FAI and release for production.
Oversee QA aspects of production process control (P PC).
Support and manage CAPA, nonconformances, and complaint investigations.
Conduct root cause analysis and drive corrective and preventive actions.
Approve materials, products, and production-related documentation for release.
Support process validation, equipment qualification, calibration, and preventive maintenance.
Requirements: 2 years of experience in QA / QC in the medical device.
Bachelor's degree in quality engineering, Mechanical Engineering, Industrial Engineering, or related field All relevant QA Procedures.
See training matrix QAD-001
Self-reading of all indicated documents
Deep knowledge and understanding of product DMR including
practical training
Quality Control On-the-Job training by Sofwave qualified QC
Evidence of proper execution of QC tests and certification
Performance impression by QA Manager.
This position is open to all candidates.