• Internal auditor – performed 95% of all internal audits conducted annually by QA; audits performed were instrumental in improving the fab, test and back end operations of the company and ensured that these operations were ready for subsequent ISO 9000 audits.• Supplier auditor – performed 100% of local supplier audits conducted annually by QA; audits performed were instrumental in ensuring that only ISO compliant and certified local suppliers were maintained on the company’s qualified suppliers list (QSL).• United Laboratories (UL) audit point of contact – responsible for demonstrating the company’s compliance to UL requirements; passed all UL audits from 1999 to 2015 to allow the company to retain its UL certification.• Corrective and preventive actions (CAPA) program manager – revised this program into a more efficient and reliable tracking and reporting system; improved the effectiveness of this program by emphasizing detailed follow up on all completed corrective actions; this program successfully passed each ISO 9000 and ISO 14000 audit from 1999 to 2015. This program dealt with an average volume of 130+ CAPA’s annually.• Offsite records storage manager – managed the movement of company records in and out of three offsite storage locations; monitored and maintained the inventory status of records at each storage site; coordinated and verified the destruction of all expired records; coordinated the final draw down and closure of each storage site which, in the aggregate, was costing the company an average of $40,000 a year to maintain.• SPC – used SPC tools to present internal audit, supplier audit and CAPA activity in periodic reports to management. Used pareto, xbar-R and standard deviation tools for data analysis and presentation.• Documentation – as necessary, initiated, updated or obsoleted QA-related specifications and procedures; used ECN/TECN process to affect document changes; worked extensively with BOM, RSIC and connect sheet documents.

• QA operations – managed and directed the day-to-day operations of the company’s four person QA staff.• ISO 9003 certification – managed the company’s ISO 9003 certification program; joined the company after it had received four major discrepancies in its 1996 ISO audit and was in jeopardy of losing its ISO certification; coordinated the correction of these major discrepancies and successfully passed the next ISO audit with only three observations; this success allowed the company to maintain its ISO certification.• Corrective and preventive actions (CAPA) – managed the company’s corrective and preventive actions (CAPA) system; initiated the active collection of supporting data and documentation to evidence corrective action implementation and effectiveness; initiated a monthly CAPA summary report for senior management; reduced CAPA cycle time by 70%.• Internal auditor – responsible for implementing the company’s internal audit schedule; performed all scheduled internal audits; followed up on all corrective actions resulting from these audits; integrated the internal audit corrective actions into the company CAPA system.• Document control – managed the company’s document control system; wrote Level II procedural documents to close gaps in the document structure; improved document change control by developing and implementing a formal ECN process; implemented full life cycle document control procedures to further formalize and control the DCS process.• Training – responsible for re-organizing the company’s training files; ensured that all personnel had up-to-date certificates of training on file; developed and implemented a company quality awareness training course; developed and implemented an annual cyclical training course for the QA staff.