• Authored the Post Market Surveillance Report, which assessed the HVAD system's performance through a review of complaints data, sales data, field returns data, patients data, issue escalations, health hazard evaluations, CAPAs, Supplier CAPAs, Service Records, Vigilance Data, changes in design and manufacturing processes, IFU or the risk management file. • Performed Health Hazard Evaluations, which documents the potential risks to users related to an issue, including issue investigation, bounding, health hazard assessment, and the decision to perform field action or not. • Maintained the data monitoring plan with thresholds set for ongoing post market monitoring of issues. Investigated the threshold breaches and revised the risk assessment of the issues.• Managed the issue escalations and decision process of issues that may impact distributed product. Documented the failure analysis, complaint review, risk analysis, regulatory compliance and closure decision.• Drove the field action process from planning, execution, reconciliation for effectiveness checks to closure as a Field Action Coordinator. Created a detailed Field Action Implementation Plan based on the approved high level field action strategy from management. • Managed the development of field safety notices to consignees and patients. Coordinated the final preparation and distribution of Field Safety Notices.• Tracked the responses and completion of required actions by the consignees and patients. Developed metrics and provided periodic progress reports. • Drafted and submitted initial and interim field action reports to regulatory agencies including 21 CFR 806 report, MEDDEV EU FSCA Report, TGA reports, and others as needed. Managed, prepared, and tracked timely submission of responses to regulatory agencies requests.• Documented the internal field action plan closure report. Submitted final external field action closure reports to the regulatory agencies.

• Ensured that Corrective/Preventive Action (CAPAs) are well-defined, executable, meet customer and business needs, and are in compliance with regulatory requirements. • Collaborated with CAPA owners to ensure timely completion, introduced tools and techniques to breakdown complex business problems into manageable tasks, and facilitate the team efforts. • Led weekly PAR (Prioritize, Assign, Resources) CAPA meetings with senior management to report on CAPA progress and to escalate any concerns with resourcing or prioritizing CAPAs. • Analyzed and reported CAPA trending results to senior management. Provided J&J Vision Care CAPA performance metrics for J&J MDD metrics reporting.• Developed reports to monitor trends of NCs and CAPAs data from the EtQ environment.• Led critical tasks to ensure successful deployment and transition of the from J&J Vision Care CAPA quality system to J&J Medical Device Diagnostics (MDD) CAPA quality system. • Evaluated the CAPA ETQ system, procedures, and standards to identify areas for review, change, or elimination. Established and ensured linkages to other key quality systems and programs.

• Supervised a team of technicians operating manufacturing lines that produced contact lenses. The 2GT team consisted of 48 technicians and the 3GT team consisted of 35 technicians.• Conducted daily production meetings with technicians, cross-functional teams, and senior management to discuss key production performance indicators such as safety, quality, delivery, and cost. • Worked closely with technicians, engineering, and support groups to identify, plan, execute, and facilitate improvements to the production yield while adhering to safety, environmental, quality procedures. • Provided coaching to the technicians during the quarterly one-on-one meetings, mid-year, and end of year performance reviews. Strategically organized resources to capitalize on the individual’s and team’s strengths.• Evaluated Non-Conformances and CAPAs for any possible root causes in manufacturing process and implemented corrections or corrective/preventive actions.• Utilized various analytical tools to analyze complex data to report parameters that directly impact the KPI of the business, such as throughput improvements opportunities, or determining the frequency of part replacements.

• Ordered and managed raw material, WIP, and finished goods inventory for Strongback Assembly line. Scheduled, tracked, and adjusted inventory to support production orders until completion. • Coordinated with Production Supervisors to ensure material availability for the shift. Worked closely with Suppliers, Purchasing and Expediters to ensure On Time Delivery of material. Consulted Engineering and Quality regarding any supplier deviations or product quality issues. • Negotiated the disposition of nonconforming material by using quality inspection reports and engineering schematic drawings to prove to suppliers any deviations or damages in material.• Resolved issues of material discrepancies in the SAP database and actual inventory. Performed frequent cycle counts to correct inventory inaccuracies and to minimize inventory build-up.• Conducted Root Cause Analyses to improve material delivery and layout in stockroom and on production floor. Critical factors were inventory turnover, size, weight, and accessibility of parts.• Led Lean Action Workout project to facilitate ergonomic material handling and reduce on-hand inventory. Successfully motivated vendor to reduce batch quantity.

• Technical lead over 13 union employees assembling the Wind Gearbox. Determined daily production priorities, organized shift’s production schedule, and monitored production progress. Critical decisions made to resolve any resource, schedule, and personnel conflicts.• Managed and coordinated the entire production process from verification of material in Receiving, through Assembly, Painting, Testing, Shipment, and final verification of Bill of Lading. • Conferred with Sourcing to expedite orders during material shortages, with Engineering verify customer product specifications, and with Quality on incoming inspection and disposition of non-conformances.• Analyzed current product flow and cycle time of each workstation to model and simulate alternative product flows within the production line. Reduced overall product cycle time and streamlined processes by implementing the Lean concept of U-line Product flow.• Responsible for driving continuous improvement projects on the line. Creatively reduced the cycle time of several workstations. Set up JIT material delivery and a two bin Kanban system. Improved tools presentation. Participated in several area Kaizen events throughout the plant.

• Provided technical support to 19 upstate NY locations including: supporting departmental servers, installing and troubleshooting internal applications/software. • Managed and coordinated a large scale PC Renewal project replacing old Windows NT computers to Windows 2000/XP Pro across the 19 upstate NY locations. • Performed back-up and restoration of user’s data, secured return authorizations for old PCs, and installed and registered new PCs.• Hired and managed a LAN contractor who worked from a remote location to provide on-site technical support. Responsible for contractor’s performance management, training, and attendance. • Designed, maintained and updated the department’s intranet website using Macromedia Studio MX. Designed a Lotus Notes database to facilitate team conference calls and schedule team tasks.