• Support production activities at contract manufacturers through daily quality engineering support, process validations, test method validations, and production verification activities• Managing and improving the Supplier Management System, including implementing electronic system for supplier management and supplier control activities• Collaborate with R&D and Operations for qualification of new contract manufacturer based in Ireland• Support VP of Quality in quality systems & assurance tasks, such as internal audits, CAPAs, Supplier CAPAs, management review, document control, and training• Administrator of Grand Avenue software system for document control, training, and supplier management modules.• Responsible for managing and improving quality assurance procedures such as Risk Management, Statistical Techniques, CAPAs, NCRs, Process Validations, etc.

Medical Devices & IT Medical Device Manufacturer Internal Audits to assess Quality System compliance to FDA & ISO regulations Supplier Audits and auditor training for medical device manufacturers in South Korea Project manager for business ventures in IT, Technology, and semiconductor manufacturingInfluencer Marketing Research and develop business partnerships with global suppliers & agencies for influencer marketing Sales and project management for global campaigns

Supplier & Component Qualifications.Automated Keyence Inspection Routine Development & Validations (R&R, SWV)

Managing and Improving the Supplier Management Process. Supplier Quality Audits, Supplier Assessments, Receiving Inspection support, supplier-related NCMRs and SCARs.Manage the Risk Management Process. FMEAs, Risk Management Review, feedback system, ISO 14971:2012.Support Internal Audit Process. Conduct Internal Audits, manage and review findings and corrective actions.Corrective Actions. Root Cause Analysis, Corrective Actions, Failure Investigation Reports.MAUDE Assessment for Post-Market Surveillance.Compile & create metrics of Complaints and Sales data for Management Review.

Conducted quality system tasks such as Non-Conforming Material Control, Corrective Actions, Quality System Documents, Document Control, Complaints & MDR's, and Supplier Control.Worked with consultants for regulatory submissions in Korea, Taiwan, China, Russia, and MexicoConducted QC inspections with microscopes, calipers, micrometers, and gauges.