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.