• Perform Cost Benefit Analysis and recommend optimal solution.• Created work instructions for Validation (IQ, OQ, PQ) of Form, fill and seal packaging machine.• Conduct internal audits as a lead auditor and worked jointly with QA department.• Update quality documents, work instructions, SOPs for new product, packaging line development.• Ensure that cGMP’s are used and followed during production of products so that all FDA and international regulations are upheld. • Implemented Lean Six Sigma (DMAIC process), Value Stream Mapping, and process control plans to improve efficiency of packaging and manufacturing assembly line.• Conduct GEMBA walks to identity hurdles and eliminate them to run smooth and efficient shifts• Plan demand and manage production schedules by running Material Requirement Planning and Kanban for inventory control.• Assist QC and conduct supplier audits to ensure quality standards are met.• Leverage Netsuite ERP and QuickBooks for Inventory management.• Design the layout of warehouse and clean room to increase efficiency of the operations team, by conducting structural analyses, material flow and area planning for warehouse operations.• Work with management to compile individual and departmental performance objectives and streamline procedures.• Promote the use of safe work practices during all aspects of production and ensure all external and company policies and OSHA standards are met daily.• Participate in the design, selection, installation and qualification of new equipment, facilities, and processes.• Work collaboratively to ensure flow of product, sharing of best practices, and lean behaviors.

Responsible for recommending, developing, and reviewing QA standards, policies, and procedures for all functions involved in quality of new product, in accordance with company standards.• Recommend, develop, and review QA standards, policies, and procedures for all functions involved with or related to the quality and testing, in accordance with company standards.• Manage and maintain CAPA process for area, lead CAPA activities and root cause investigations.• Create and execute test cases while adhering to established product quality standards.• Identify, analyze, investigate, and document patterns and trends in customer complaints from the field as part of the CAPA system. • Ensure that information and insight gained from the investigations and corrective actions is fed back to the R&D and marketing team as part of the risk management to improve patient safety and product quality. • Document trend action by updating the trend report and take regulatory decisions at appropriate levels and by performing a Health Risk Analysis.• Develop test plans, procedures, justifications papers and provide engineering support for new product complaint readiness.

• Staff and implement the daily plan for Outbound team of 70+ Associates and labor share with other departments.• Manage and control 70 manual packing and 15 smart pack stations.• Practice safety initiatives and support all safety programs and OSHA compliance to ensure safe work environment for all Associates.• Train, coach and develop team of 70+ Associates to achieve operational initiatives and goals to lean continuous improvement process environment. Oversee all outbound product processing and logistics of the building.• Identify and lead process improvement initiatives in support to outbound operations.• Responsible for deep dive and analyze metrics data to determine ideal corrective actions, to increase productivity and schedule adherence goals by more than 10%. Conduct daily quality audits to ensure higher standards and reduce DPMO.• Partner closely with all cross-functional teams (HR, IT, Safety, Inventory Control, and Outbound) to drive improvement to safety, quality cost, and delivery while expanding warehouse capabilities.• Highly involved in Continuous improvement projects to target DPMO, takt time, safety, rate of production, labor movements using time studies, PFMEA, Root Cause Analysis, Kaizens and 5s.

Responsible for collaborating with professor to take ownership of workplace injuries due to manufacturing with Lathe Machine in the U.S. case study; performed scale validation, survey translation, data collection and analysis. • Investigated and analyzed 301manufacturing injuries due to Lathe reported to OSHA over the period of 35 years, by conducting Graphical Analysis, and Process Failure Modes Effect Analysis (PFMEA). • Maintained professional working relationships with teammates and all other department. Handled sensitive confidential proprietary information with discretion.

Worked directly with faculty advisor and conducted 20hours of research weekly focused on assessing 16 major U.S. manufacturing sectors in global supply chain and 6-layer analysis with Time-series MRIO Models.• Examined and analyzed U.S. manufacturing sectors’ environmental and economic outputs at the global supply chain level using 6-layer analysis.• Developed Multi-Region Input Output models for multiple countries and computed 20-year period results using R studio.• Optimized model by Data Envelopment Analysis (DEA) and benchmarked industries using eco-efficiency ratio.• Prioritized workflow and optimize time to ensure deadlines are met. Anticipated problems and proactively resolve or escalate to management when appropriate.

• Lead and coordinate foundry development through ergonomics, kaizens, associate experience, material flow and vendor communication.• Developed AutoCAD drawings for operations and Layout plans to support deep understandings and check for material and labor flow to conduct Value Stream Mapping for entire workshop and identified bottle neck operation and identified 7+ Kaizens which resulted into reduction of lead time of final product by 2 days.• Established and modified some routings, methods, tools, quality audits and labor standards according to process requirements.• Improved purchasing process by working with cross-function teams and analyze demand, inventory levels, and order fulfillment.• Designed drawings for special cutting operations on AutoCAD. Developed and executed standard operation procedures.• Analyze, develop, and implement new manufacturing practices and automation technology and prepared SOP to standardize process.• Executed Lean Six Sigma and reduced Yield Loss from 18% to 6%, which saved 3500kWh/year by using DMAIC and PFMEA. • Functioned as sole liaison with associates to ensure timely production and that the required quality and specifications were upheld. • Expertise with carrying First Piece Inspection of incoming new products from suppliers by reading Blueprints according to ISO 2014 quality standards, Bill of Material (BOM), and SAP codes with proper documentation. • Led investigations for supplier quality issues to find root cause, identify and implement corrective actions to achieve quality goals. • Documented all quality metrics reports as well as presented data and improvement planning to the factory leadership.• Expertise in Inventory Control project using ABC analysis and generated EOQ model which saved $2400 per month.• Decentralized storeroom which reduced worker movement and saved land space which costs $800 per month. • Developed detailed manufacturing instructions (SOP) to document quality critical characteristics.

Learnt about Turbines and Gas Power Plants. Gained knowledge about the working environment and layout of the company. Studied quality management of the company and its documentation with customers.