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.