Summary of Qualifications Manufacturing engineering, experienced in both Research and Development (R&D) and operations. Generated Protocols and reports documenting validation of manufacturing equipment and processes to satisfy both FDA and CE requirements (e.g., IQ, OQ, PQ, ). Participated on a R&D team that brought new products to market from concept to finished goods. Conceptualized automation of a syringe manufacturing line which when placed into production realized a cost savings of $570,000 annually. Participated in Nonconformance root cause investigation, corrective action identification. Monitored failure mode to evaluate effectiveness of corrective action. Investigated returned good, to identify failure mode and corrective action if required. Reported findings to regulatory to decide if they needed to be a notification to the FDA. If there was a reportable failure I gave input for root cause and corrective action. Basic knowledge of mini Tab. Familiar with lean manufacturing, Familiar with ISO 13485. Experience in Dispositioning. NCMR's, CAPA's, returned goods investigation (RGA) Corrective action report.

Highlights:

• Evaluate
• Manufacturing
• TIP
• Automation
• Engineering
• ISO
• Lean Manufacturing
• Manufacturing Engineering
• Microsoft Windows CE
• Research