Officer / Sr. Officer

Key Responsibilities Execute day-to-day manufacturing of urology medical devices. Prepare and maintain Batch Manufacturing Records (BMR) and production documentation. Ensure compliance with ISO 13485, GMP, and company Quality Management System. Coordinate with QA, QC, R&D, Engineering, and Supply Chain for smooth production. Monitor production output, yield, rejection, and machine utilization. Support process validation (IQ/OQ/PQ) and manufacturing transfers from R&D.