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.;
• Implement process improvements to enhance productivity and reduce waste.
• Ensure line clearance, traceability, and product identification throughout manufacturing.
• 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. Requirements Educational Qualification
• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Production Engineering, or related discipline.
• Preferred: 1–5 years of experience in medical device manufacturing. Technical Skills Required
• Medical device manufacturing processes
• ISO 13485 & GMP




• Good Documentation Practices (GDP)
• Process Validation (IQ/OQ/PQ)
• Lean Manufacturing & 5S
• Root Cause Analysis (5 Why, Fishbone)
• SAP/ERP production transactions
• Microsoft Excel & production reporting Competencies
• Solid analytical and problem-solving ability
• Cross-functional collaboration
• Attention to detail
• Communication skills
• Ownership and accountability
• Continuous improvement mindset Benefits Hiring this role will provide the following

benefits:
• Increase manufacturing capacity for the expanding Urology Solutions portfolio.
• Reduce production bottlenecks and improve on-time order fulfillment.
• Strengthen compliance with ISO 13485 and regulatory manufacturing requirements.
• Improve process efficiency, yield, and overall equipment utilization.
• Support successful transfer of new products from R&D; into commercial manufacturing.
• Enhance documentation accuracy and reduce deviations, NCRs, and rework.
• Enable scalable production for CE, RoW, and future global market expansion.

📌 Officer / Sr. Officer (Killa-pardi)
🏢 Meril
📍 Killa-pardi