Collaborate and develop enterprise Supplier CAPA Process. Influence management to gain process acceptance.TrackWise Super User. Track Wise UI Tester.

Manage CAPA process. Ensure Documentation is compliant and is audit ready. Analyze quality metrics for continuous improvement opportunities.Provide oversight and guidance on CVG Supplier CAPAs to CAPA owners. CAPA Coach. Root Cause Specialist. Corrective action influencer.Over the course of the position, reduced ineffective CAPAs by 50%. Ruduced portfolio from 45 CAPAs to 13.

Principal Supply Chain Quality EngineerContinuous improvement in supplier controls with a focus on contamination controls.Project leader and CAPA owner. Lead enhancements to the QMS.Audit Coordinator/ Quality Management System Principal Quality EngineerOrganize audit activities, develop quality system to ensure continued compliance, lead audit finding response plan's organization. Manage Quality System, drive Quality System improvements. Manage changes as CAPAs or as audit Response Plans.

Act as a Quality Systems consultant on behalf of Medtronic. Assess suppliers' current quality system against Medtronic requirements. Any gaps revealed during the assessment require improvement plans. Create and lead the improvement plans to completion to meet Medtronic's requirements. After working for two months with SQA, I was promoted to a peer reviewer / technical advisor role. Perform technical reviews on peers' assessment reports and improvement plans. After two months in this role, I was elevated to QE Lead. New duties include training new QEs, directing QE activities and providing guidance when path forward is not standard.

ISO 9001 and 13485 Certified. Create and implement quality plans (FMEA, CP, DOA, CMM, SPC, and PPAP) for new products. Resolve quality and process issues using root cause analysis techniques. Maintain internal and external CAPA system. Created system to collect operations and scrap data. Maintain and analyze operations and scrap data.

Perform process analysis using lean and six sigma analytical tools. Lead continuous improvement initiatives and be the primary liaison for customer quality concerns (CAPA). Create and follow through on DOEs and CPs for new and existing product. Implemented and maintained the company-wide SPC system.

Perform process and design engineering duties in the K-Area nuclear reactor at the Savannah River site. Divisional Engineering Project Manager. Local Safety Improvement Team leader. Supervise and coordinate waste sampling activities to determine proper disposal path.

Implement, maintain, and audit ISO9001. Monitor intermediate and final product characteristics to identify and resolve process issues. Organize laboratory activities and oversee product testing. Train laboratory technicians proper laboratory techniques and ensure SOPs are followed. Manage lab personnel to maintain proper testing for a plant that operates 24/7.