A global provider of temperature and gas sensing solutions to clean technology, energy, solar, industrial and medical markets.Responsible for Quality System Maintenance Maintain company compliance with FDA Quality System Regulations, ISO 13485 and ISO 9001 standards Direct support for FDA and ISO inspections and registration Certified ISO 9001:2015 and ISO 13485:2016 Lead Auditor. Trained and lead team of auditors. Initiate and support investigations pertaining to observations made during audits and ensure that deviations are addressed in a timely manner and that corrective actions meet company and regulatory requirements Manage suppliers’ performance, approval and qualification of new / revised items which includes inspection method and validation Manage supplier corrective and preventive actions Responsible for continual product/process improvement activities to enhance the quality system. Effectively apply techniques like SPC, FMEA and DOE to drive product / process improvements Perform, coordinate, and participate in root cause analysis and corrective action determination to provide resolution to customer complaints, non-conforming material disposition and process variation

Touchscreen and Touch Computer TechnologiesManaged the global CAPA and Internal Audit systems for adherence to ISO9001:2008.Trained and certified audit staff. Planned and conducted monthly Internal Audits by department.Facilitated investigation and closure of customer complaint and internal corrective and preventative actions in a timely manner by utilizing 8D and DMAIC principles.Working in conjunction with the Design and Process Engineering groups in utilizing DFMEA and PFMEA mechanisms, I designed and implemented many continuous process improvement metrics.Planned and hosted outside auditor visits for surveillance and recertification to ISO9001:2008.In collaboration with the QA group, I planned, created, and helped to present bi-annual Management Review reports to the Senior Management Team.

Directed all quality functions pertaining to the scanning of University library materials and commercial publishers’ books and catalogues into Google’s search engine.Utilizing ISO9001 principles along with Kaizen, SPC, FMEA and Quality Metrics, I was instrumental in creating an environment of continuous process improvement for our group. Managed and supervised the training of 80 QC personnel to perform tasks utilizing a Linux based system to ensure that the images produced are of the highest quality possible. Updated training SOP to enhance the performance of QC personnel based on ongoing changes in the process.Implemented a 5S program to instill good housekeeping habits in the facility.

Directed all quality functions pertaining to Cisco Systems products. Planned and documented assembly and testing process procedures for such projects as: Abbott Labs: (medical diagnostic equipment) Baxter: (medical diagnostic equipment), Sun Micro: (routing systems), Juniper: (routing systems), Cisco Systems: (routing systems), Brocade: (switching systems), EMC: (routing systems). Trained and audited the internal staff on ISO 9001:2000 quality system principles, which led to its successful implementation and increased our customer base by 50% and made for a vastly more efficient quality process.Planned and instituted Kaizen events for assembly lines that resulted in a decrease of line staff by 40% and an increase of quality yield by 10%. It was a win-win situation because we used the extra line staff on new projects and our customers and we reaped the greater yield benefits.Instituted in collaboration with Cisco Systems a Six-Sigma quality program to measure defects per unit that is a more highly tuned vehicle than just measuring total defects only. Using this methodology, we lowered our DPU level to 0.02.By facilitating the training of personnel and leading internal audits, I prepared the company for the successful qualification in conformance to ISO 13485, GMP and FDA regulations for a major medical OEM. The resulting manufacturing contract led to $12M in added revenue over the life of the project.