Rajesh Mohapatra

Process Improvement:
• Achieved 3% cost savings by implementing ERP systems for optimized production scheduling and resource planning.
• Reduced equipment downtime by 7% through a well-planned preventive maintenance schedule.
• Reduced production cycle time by 2% through process improvements identified through root cause analysis and problem-solving techniques.
Quality Assurance:
• Execute IQ/OQ/PQ protocols, develop testing protocols, conduct verification/validation, first-article inspections, maintain DMR/DHR.
• Reduced non-conformance rates by 12% through the implementation of improved inspection plans and corrective actions.
• Improved product quality by 8% through the development and implementation of effective testing protocols.
Equipment Management:
• Plan and execute equipment maintenance, provide support for installation, repair, and calibration.
Validation:
• Successfully validated 5 new machines involving medical devices, ensuring compliance with regulatory requirements.
Compliance & Documentation:
• Review technical documents, conduct internal audits, analyses customer complaints.
Regulatory Compliance:
• Ensured 100% compliance with regulatory requirements through the accurate maintenance of DMR and DHR.
Overall:
• Contributed to a 6% increase in overall production efficiency through effective quality assurance practices and process improvements.

Project Management:
• Achieved 33% project completion on time by effectively managing timelines and resource allocation.
• Improved client satisfaction by 21% through consistent communication and proactive issue resolution.
Product Development:
• Successfully implemented 15% new product features within the specified timeline.
• Ensured 100% compliance with UDI and 2D Data Matrix requirements through thorough feasibility assessments and design updates.
PLM (Product Lifecycle Management):
• Streamlined inspection sheet updates by 9% through efficient use of Windchill and Agile.
• Reduced change order processing time by 20% through optimized routing procedures in Windchill and Agile.
Overall:
• Contributed to a 10% increase in product development efficiency through effective project management and PLM practices

Product Testing and Evaluation:
• Reduced product defects by 17% through the development and implementation of effective test protocols.
• Ensured 100% compliance with product specifications through rigorous testing and evaluation.
Process Improvement:
• Achieved 10% cost reduction through process optimization initiatives.
• Increased production efficiency by 28% by implementing process improvements and reducing waste.
Project Management:
• Successfully completed 13 special projects related to process improvement and cost reduction within the specified timeline.
• Reduced project costs by 8% through effective project management and resource allocation.
Technical Expertise:
• Resolved 15 to 20 manufacturing process issues through timely troubleshooting and technical support.
Data Analysis:
• Identified 9 areas for process improvement through data analysis and identified trends.
• Reduced process variability by 6% through data-driven changes.
Validation: Successfully validated 70 new machines involving medical devices, ensuring compliance with regulatory requirements.
Methodologies: Effectively applied APQP, PPAP, FMEA, and other quality tools to drive process improvement and risk management.
Documentation: Ensured 100% compliance with documentation requirements through the creation and maintenance of essential process documentation.
Cross-functional Collaboration: Successfully collaborated with cross-functional teams to achieve process improvements and product success.
Quality Assurance:
• Reduced customer complaints by 18% through effective quality assurance practices and proactive issue resolution.
• Ensured 100% compliance with quality standards through rigorous inspection criteria and testing.
Regulatory Compliance: Maintained 100% compliance with FDA and EU MDR regulations through meticulous documentation and adherence to standards.
Overall:
• Contributed to a 38% increase in overall production efficiency through effective product testing, process improvement, and quality assurance practices.

Product Development:
• Successfully developed 12 new products from concept to market launch.
• Reduced product development cycle time by 10% through efficient design and prototyping processes.
Technical Support:
• Resolved 15 technical issues related to machinery and equipment, minimizing downtime.
• Improved equipment efficiency by 12% through technical guidance and support.
CAD Proficiency:
• Created 25% technical drawings with a accuracy rate.
• Reduced design errors by 20% through precise CAD modeling.
Quality Assurance:
• Reduced product defects by 11% through effective inspections and reviews.
• Ensured 100% compliance with quality standards.
Lean Manufacturing:
• Achieved 8% cost reduction through Lean manufacturing initiatives.
• Increased production efficiency by 18% by implementing Lean techniques to reduce waste.
Tool Design: Reduced production time by 6% using optimized tooling.
Problem Solving:
• Identified and resolved 17% root causes of production issues through effective problem-solving ideas.
• Improved process stability by 14% through the implementation of corrective actions.
Process Optimization: Evaluated manufacturing feasibility and conducted FMEA analysis.
Production Planning: Finalized production layout, balanced lines, and planned manpower.
Production Management: Oversaw daily operations, schedules, and material optimization.
Inventory Management: Implemented Kanban system for efficient production flow.
Overall:
• Contributed to a 16% increase in overall production efficiency through effective product development, technical support, and process improvement initiatives.