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
- Positive 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.
📌 Officer / Sr. Officer (India)
🏢 Meril
📍 India