Responsible for coordinating compliance activities and audits by working with various internal groups of client organizations and outside auditors.Provide GCLP/GCP and ISO compliance and auditing support by performing audits of manufacturing floors, laboratory facilities, generate reports and data for executive managementSetup framework and implement CAPA (Corrective Action Preventative Action) framework for client organizationsDevelop, re-engineer processes and SOPs including protocols, amendments, sample case report forms, and sample informed consent forms for adequacy and compliance.

• Provided Quality Engineering support for Manufacturing of anti-hemophilia pharmaceutical products• Responsible for incoming non-conforming materials, analysis and subsequent disposition of materials (rework, use as-is or RMA to supplier)• Led monthly CAPA (Corrective Action Preventive Action) to classify, prioritize, and disposition of quality issues identified via customer support, internal audit and return merchandize (RMA)• Worked with cross-functional team in root cause analysis and corrective solutions• Closely worked with line-leads in improving FPY (First Pass Yield) percentage and reduction of fall-out (scrap)• Performed the role of an internal auditor of manufacturing processes and tools – issue CAR (Corrective Action Report), ensure implementation and compliance with KPIs for Quality Goals• Reported safety hazards and work-related injuries to supervisor or area Manager immediately supervise staff, develop goals, establishes work priorities, and assign work orders in JD Edwards (JDE)

• Led a five-person Quality team and provided quality analysis and guidelines for 4 major processes and product lines• Organized personnel into project teams and managed team activities to meet objectives and deadlines• Represented company at trade shows, conferences and public events promoting product quality and safety• Completed/tracked work orders and provide QC and functionality review for new/existing processes and products• Developed Validation Tests for micro panels, simulations for controls/sensors, memory clock, and CNC machine operations• Provided oversight and hands on testing, troubleshooting and modification of major and minor systems: LCP’s, sensors, transformers, AC/DC high‐low power control cards, memories, LED’s and relays. Inspected controls, sensors, and systems including online MODEM control & CAT 5 crimp connections

• Established safety SOP’s promoting a safe work environment for the Rail Central Control (RCC), Yard Control• Guided preventative maintenance solutions and troubleshooting for ATP systems, automatic doors, sprocket/pulleys, conveyer belts, pumps, Brake Control Units, and more for LRV system/SIEMENS Rail P2000• Inspected/tested electrical/mechanical/pneumatic systems: Main line Traction Power, BCU, HSCB and more