Arun Sharanu

Results-driven professional with over 9 years of experience in Engineering Change Management (ECR/O), leveraging SAP ECC 6.0/MM and SAP GRC to optimize processes. Expertise includes comprehensive SAP end-user support in Production Planning & Control (PPC) and a strong foundation in Quality Management Systems (QMS) and regulatory compliance for medical devices, including ISO 13485 and EU MDR. Proven track record of supporting R&D initiatives, enhancing cross-functional collaboration, and driving continuous improvement through effective CAPA lifecycle management and data analytics using Power BI.

Achievements include delivering significant business impact with annual cost savings of ₹22 lakhs while ensuring alignment with production planning and maintaining audit readiness across global projects, as well as developing a reporting tool valued at $0.125M using Power BI and Power Automate.

Lead Engineer at Becton Dickinson (payroll - HCL Technologies Limited) (2021-06 – Present)

• Coordinated worldwide QA and R&D support for QMS, design documents, drawings, and BOMs.
• Created ECRO in SAP to update production data (BOMs, task lists, materials, and documents).
• Released manufacturing and specification documents through SAP ERP.
• Managed end-to-end user provisioning via CUP/ARM requests (account creation, role changes, access control). Assisted in periodic User Access Reviews (UAR) and supported SOX/internal audit requirements with documentation.
• Led the Risk Management Process (RMP) including identification, analysis, evaluation, and control.
• Conducted PHA, Use Case Analysis, and FMEA (Design, Process, Manufacturing) for risk assessment.
• Implemented and validated risk control measures, and managed residual risk evaluation (ORR).
• Maintained Risk Management Reports (RMR) and supported post-production risk monitoring.
• Managed CAPA lifecycle including identification, RCA (5 Why, Fishbone), implementation, and closure.
• Tracked CAPA effectiveness and ensured prevention of recurrence.
• Handled non-conformance reporting (NCR) and coordinated timely resolution.
• Supported QMS processes including audits, documentation, and compliance.
• Participated in internal/external audits ensuring adherence to quality standards.
• Maintained documentation for regulatory compliance and quality reviews.
• Contributed to customer feedback, complaint handling, and quality improvement programs.
• Collaborated with stakeholders to drive continuous improvement initiatives.
• Developed a reporting tool worth $0.125M using Power BI & Power Automate.
• Created PRM templates and automated reporting solutions to save organizational time.
• Built automated data refresh pipelines ensuring real-time visibility of quality and risk metrics.
• Designed interactive Power BI dashboards to monitor Risk Management KPIs (RPN, severity trends, residual risk).
• Built CAPA tracking dashboards to visualize open vs closed actions, aging analysis, and effectiveness status.
• Developed supplier quality and audit dashboards to track performance, compliance, and closure status.
• Integrated data from SQL, Excel, and SAP into unified QMS reporting solutions.
• Used DAX calculations for KPIs such as CAPA closure rate, defect density, and risk exposure.
• Implemented Row-Level Security (RLS) to restrict access to sensitive quality and risk data.
• Designed trend analysis dashboards to identify recurring issues and support preventive actions.
• Created drill-down reports for non-conformances, complaints, and audit findings.
• Enabled management review reporting with executive-level dashboards for decision-making.
• Supported continuous improvement initiatives by providing actionable insights from analytics.

Engineer at Steel Strips Wheels Limited (2015-11 – 2020-12)

• Prepared and maintained Standard Operating Procedures (SOPs), manuals, and work instructions for production and quality processes.
• Developed Control Plans, Process Flow Charts (PFC), and PFMEA for manufacturing operations.
• Supported PPAP documentation including submission and compliance requirements.
• Ensured proper process documentation and standardization across operations.
• Managed SAP-based inventory control including stock monitoring, material movements, and reconciliation.
• Created and processed Purchase Requisitions (PR) and converted them into Purchase Orders (PO).
• Handled Goods Receipt (GRN), stock transfers, and material tracking in SAP.
• Developed and executed production plans based on marketing demand and forecasts.
• Monitored production schedules, output, and capacity utilization, ensuring timely order creation and confirmation in SAP.
• Coordinated with procurement, warehouse, and cross-functional teams for efficient inventory and production management.
• Conducted rejection analysis and implemented Corrective and Preventive Actions (CAPA).
• Performed root cause analysis (5 Why, Fishbone) for non-conformances and quality issues.
• Ensured effective non-conformance handling and resolution.
• Supported QMS processes including audits, compliance, and documentation control.
• Drove continuous improvement initiatives based on CAPA and audit findings.
• Led risk management activities including identification, analysis, evaluation, and mitigation.
• Conducted FMEA (Process & Manufacturing) to assess risk severity, occurrence, and detection.
• Implemented risk control measures and validated effectiveness.
• Managed residual risk evaluation ensuring compliance with acceptable risk levels.
• Maintained risk documentation and reports ensuring audit and regulatory compliance.
• Maintained OEE practices, TPM, and QC tools in the plant.
• Assisted in audit readiness and documentation control.
• Coordinated with cross-functional teams for continuous improvement and on-time delivery.
• Compiled and maintained all TS and audit documents for production departments, ensuring compliance and readiness.
• Supported TS16949 transaction processes and successfully handled surveillance audits, strengthening organizational audit preparedness.
• Achieved annual cost savings of ₹22 lakhs by reducing blank sizes of various parts.
• Streamlined material usage and improved efficiency in production processes.
• Reduced non–value-added activities across multiple process flows, enhancing productivity and operational efficiency.
• Supported continuous improvement initiatives through lean practices and structured problem-solving.

B.E in ME – Adithya Institute of Technology (2015-04)