Officer / Sr. Officer
Core
Execute day-to-day manufacturing of urology medical devices, ensuring compliance with ISO 13485 and GMP while coordinating cross-functional teams.
Role type
Manufacturing Officer / Sr. Officer (Medical Devices)
Builds
Urology medical devices
Domain
Medical Device Manufacturing / Urology
Required skills
Medical device manufacturing processes, ISO 13485 & GMP, Good Documentation Practices (GDP), Process Validation (IQ/OQ/PQ), Lean Manufacturing & 5S, Root Cause Analysis, SAP/ERP, Microsoft Excel
Preferred skills
1–5 years of experience in medical device manufacturing
Technologies
SAP/ERP, Microsoft Excel
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, Monitor production output, yield, rejection, and machine utilization, Support process validation (IQ/OQ/PQ) and manufacturing transfers from R&D, Implement process improvements to enhance productivity and reduce waste, Ensure line clearance, traceability, and product identification, Participate in deviation, CAPA, NCR, and root cause investigations, Train operators on manufacturing procedures and good documentation practices, Maintain 5S, safety, and cleanroom discipline in production areas