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. 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 Strong 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.