• Successfully updated and certified the QMS system to ISO 13485:2016 for multiple sites • Development of Control Plans, Failure Mode and Effects Analysis, Process Flows, measurement systems analysis (MSA) for customer components.• Implement an environmental, health and safety program• Plan, organize, direct and report on all quality-related activities at the facility• Develop, train and coach employees on company processes in quality and safety• Perform process and equipment validations• Manage the Internal Audit, SCAR, and CAPA processes at the facility• Establish and drive cultural standards of Quality, Service, Safety, Performance and Teamwork• Work with customers to develop inspection protocols and train staff to them• Work directly with all levels of the organization to develop best practices and standardize procedures across all levels of the company.• Analyze and trend quality metrics to identify opportunities for improvement.

• Quality Management System and ISO Administrator• Responsible for the development, implementation and maintenance of site Quality Plan• Implement and manage the site Statistical Process Control program o Communicate feedback to company and Federal Government on contractual milestoneso Identify areas of continual improvement opportunities through trend analysis• Interact with Government personnel to identify customer expectations, ensure contractual obligations are being met and promote customer communication• Manage and inspect subcontracted construction projects (Utility, housing, facility projects) • Review engineering projects for accuracy and clarity• Develop, implement, and manage continual improvement projects to improve efficiency, process and/or communications • Mediator for internal and external issues with customers, vendors, and internal departments• Initiate and implement corrective / preventive actions to get projects back on schedule• Lead Auditor to ensure compliance with Quality Plan, contractual and regulatory obligations• Managed government supplied equipment and GSA vehicles• Obtained and maintained a “Secret” security clearance

Successful implementation and certification of AS9120:2009 •Interface effectively with all levels of customer and vendor management, to improve quality, and the supply chain business model•Corporate Quality Management system administrator•Work with suppliers to resolve problems with materials and the supply chain•Counterfeit Mitigation Administrator•100% on time for Customer corrective / preventive actions•Customer quality contact for all quality matters•Lead Auditor for supplier and internal audits

Corrective Action and Preventive Action and Complaint system administrator•86% increase in CAPA on time performance•50% decrease in turnaround time•Lead Internal and Supplier/Subcontractor Auditor for regulatory compliance to ISO17025 and the FDA CFRs•External Audit Host for customers•Change Control administrator

Development and implementation of an ISO 13485 and cGMP Quality Management System •Assist in maintaining a compliant ISO 9001 quality management system •Developed a new Quality Manual that incorporates ISO 9001; ISO 13485; ISO 14001; OSHA 18000; and FDA Quality System Regulations. •Utilize Corrective Action/ Preventive Action problem solving techniques to reduce internal and external failures. •Manage projects that result in significantly improved efficiency, quality, health and safety.•Validate and qualify new production equipment and molds•Determine capacity of new molds.

Management and implementation of the Quality Management and site safety programs•Implemented and managed the site Statistical Process Control program for the Kitting/Distribution departments•Implementation, training, and management of the site Internal Auditing and Corrective Action/ Preventive Action programs •Facilitate standard implementation, certification, and maintenance for ISO 9001:2000 •Determine effective and efficient solutions to business process problems, opportunities, and challenges by mapping current businesses processes, identifying ideal process states, and recommending solutions. •Interface effectively with customers, to improve quality, and business model•Design and implementation of a Pull manufacturing system, using Lean Manufacturing techniques resulting in: 78% increase in floor space 25% increase in productivity •25% decrease in site production and logistics defects Quality Assurance and Process Supervisor; ModusLink, Lindon, Utah; January 1999 – November 2004•Development and maintenance of the corporate quality standards for CD manufacturing, duplication, kitting and distribution •Development, implementation, and maintenance of injection molding equipment processes and training modules. •10% increase in inventory accuracy •Internal trainer for company operational plans and procedures •Developed and analyze metrics for opportunities of improvement, find and implement solutions resulting in a 4% decrease in manufacturing scrap•Lead Internal Process Auditor for ISO 9001:2000, 14001, 13485 compliance and for company standards, policies, and procedures •Well versed in process analysis and a strong ability to recommend procedure/process changes, to include •Root cause analysis of problems.