Dhananjay Sood

Leadership & Team Development: • Directed MES teams, driving deployments, process optimization, and operational sustainability to enhance manufacturing performance and regulatory compliance. • Built and led a high-performing, diverse team, aligning talent with organizational goals and fostering engagement, accountability, and growth. • Delivered targeted training on GMP, compliance, and engineering practices, strengthening cross-functional team capabilities. Operational Excellence • Manufacturing Dashboards: Automated OEE dashboards, reducing downtime, increasing yield, and lowering scrap rates. • Quality Dashboards: Developed Power BI dashboards for executive insights, enabling data-driven decisions and organizational development. Manufacturing & Quality Expertise • Served as SME for manufacturing, quality, and compliance systems, troubleshooting issues and implementing poka-yoke solutions. • Represented MES during regulatory audits (FDA, TUV, BSI, MFDS), providing expert insights on manufacturing and quality systems. • Reviewed/approved system changes, technical designs, and GxP documentation as a Change Request Approval Board member. • Led CAPA, root cause analysis, and NC resolution to improve process controls, quality assurance, and compliance. Financial & Resource Management • Managed FY23,24 budgets, achieving project goals while optimizing costs and resources. • Allocated resources using Planisware software, supporting project execution through FY31. Validation • Collaborated with cross-functional teams and developed procedures and standard protocols to execute validation runs (IQ/OQ/PQ) using existing electronic systems, SAP, MES, and MHCS. This led to swift documentation and enabling quality enforcements. • Directed CSV activities, driving validation, scheduling, training, and compliance for timely delivery. • Spearheaded MES upgrade from Siemens Camstar 7.8 to Opcenter 2310, ensuring on-schedule deployment with zero system defects.

Continuous Improvement (CI) Initiatives • Championed CI efforts across departments, leading Gemba walks, Kaizen events, and process evaluations. • Designed and managed projects to optimize processes, reducing Non-Value-Added (NVA) time, enhancing quality enforcement and improving system usability. • Achieved 94% reduction in time spent per shift for material issuance. Training and Coaching • Trained and mentored new engineers and cross-functional teams, fostering technical expertise and collaboration. • Implemented a structured weekly training program for new shop floor hires, improving adaptability to MES for swift onboarding. Change Management and Validation • Conducted impact assessments for change requests across product lines, ensuring comprehensive evaluation and seamless implementation of changes. • Continuously refined validation protocols and change management procedures, addressing defects to improve implementation and system reliability. Documentation and Standardization • Authored and revised complex MES documentation, including SOPs, control plans, and training materials maintaining compliance and operational clarity. • Streamlined implementation practices and protocols by collaborating with other company sites, ensuring standardization, regulatory adherence and scalability across corporate sites. Cross-Functional Leadership • Facilitated collaboration between Operations, Engineering, and IT to identify opportunities for improvement and establish Key Performance Indicators (KPIs). • Delivered monthly presentations of KPIs and quality metrics to site leadership, driving data-informed decisions. Operational Support and Audits • Provided quality and system support for manufacturing operations across three shifts, resolving issues promptly to maintain operational continuity and compliance. • Supported as a Subject Matter Expert (SME) for MES during audits, project reviews, and process design activities.

Quality Engineer, MES at Terumo Medical Corporation

• Assisted production team with statistical analysis for continuous improvement projects. Worked with project engineering team on validations (IQ, OQ, PQ) • Performed supplier quality audits and worked with supplier quality team to address customer complaints and calibration issues. • Developed inspection and control plans to reduce re-occurring process defects. Trained the process team on implementing the inspection plan for a continuous production flow. • As part of training protocol, received training on agile scrum methodology for project management, use case modeling for process analysis & process validation protocols. • Conducted regression analysis and Gage R&R testing to establish relationship between process variables and establish process capability. • Worked with manufacturing engineering team on identifying and eliminating NVA time in production flow. Achieved 29% reduction in lead time.

• Carried out Root Cause Analysis for identification of root causes pertaining to the defects / stakeholder complaints and participate in CAPA activities. Implemented corrective action process for eradicating the identified root causes. • Conducted parameter checks and documented all processes for ensuring quality standards are met to avoid future defects / failures. • Developed project plans based on scope, stakeholder requirements, schedule, resources and industry regulations. Led project teams and managed all activities of the project life cycle including planning, execution, controlling and closing. • Prepared and maintained legal documents such as commercial invoice, Bill of Lading (BOL) and Bill of Material (BOM) for overseas shipping of material and equipment. • Analyzed data and prepared project reports upon completion containing statistics for slack, waste and efficiency study. • Oversaw the execution of projects for timely delivery of scope, maintaining quality and assessing and mitigating risks. • Sourced material and equipment for assigning to projects in accordance with specific project requirements and health & safety regulations.

• Collaborated with Head of Operations – Auto Products on improving the assembly process and reducing number of defects. • Implemented lean methodology (5 Why Analysis, Pareto Analysis, Value Stream Mapping, Kaizen) aimed at optimizing the assembly process of shock absorbers and reducing waste. • Successfully reduced lead time of suspension assembly by 21% by eliminating non-value-added time. • Coordinated with the inventory department on designing new storage unite for finished products to improve the production flow.