- Manage Quality Systems, including Management Controls, Complaint Handling, CAPA, Internal and External Audits, Document Control, Records Management, and Training.- Responsible for the EtQ Reliance electronic Quality Management System. - Drive continual improvement.

- Lead Internal Audits, including planning, scheduling, and conducting audits and tracking resulting actions to completion.- Coordinate and conduct Quality Review Board meetings; Coordinate Management Review meetings.- Manage CAPAs. Provide guidance and worked with CAPA owners to facilitate root causes analysis and ensure quality, compliance, and timeliness of CAPAs.- Supported external audits as a subject matter expert, back-room manager (coordinated requests and conducted document reviews), and scribe - Regularly identify opportunities to streamline and improve Quality System processes, and implemented changes.

- Customized and implemented new Quality Management System procedures, to ensure alignment and improve compliance.- Developed meaningful metrics and instituted the monthly Quality System Metrics Dashboard & Review Board meeting. - Led Internal Audits and coordinate data collection for Management Review meetings.- CAPA Engineer, responsible for overseeing overall compliance to all CAPA related activities.- Provided quality guidance on sustaining engineering activities and design control projects. - Supported execution of annual H2O2 Sterilization Validation, including the development of validation protocol and product functional testing requirements.

- Hold staff meetings, conduct performance reviews, manage timecards and vacation requests. Regularly meet with staff individually for mentoring and development planning.- Manage CAPA, Change Management, Document Control, Records Management, and Microbiology quality systems.Site CAPA Manager, responsible for overseeing overall compliance to CAPA related activities.- Develop Quality Plan and provide data for annual product reviews.- Support internal and external audits as a staging room manager and subject matter expert, resulting in zero nonconformities to date. - Integrated Quality System procedures, processes, and systems following the acquisition ensuring a streamlined and efficient company merger.- Instituted a monthly Quality System Review Board meeting to ensure site visibility into the Quality System, which became a benchmark within the Cordis franchise.- Managed and conducted quarterly Management Review Board meetings. - Led the project to redesign the ERP system to utilize R&D functionality and provide additional procurement controls, improved lot traceability, inventory, and planning.- Direct weekly Change Review Board meetings, a formal cross-functional review of proposed product design changes to review design control, regulatory, budget, resource, and/or timeline implications ensuring alignment across functions and sites.- Manage changes in products, processes, and documentation governed by external regulations and ensure all changes are controlled in accordance with requirements. Responsible for Product Data Management, including product family, routers, and Bill of Material (BOM) records as well as batch record review. Maintain the records management database and activities.

Partnered with Information Technology (IT), Software Quality Control, Finance, and Process Excellence departments to successfully develop and deploy the global Nonconformance electronic system on time. Worked directly with record owners to conduct root cause analysis and complete CAPA records.Prepared and conducted monthly Nonconformance and CAPA meetings. Developed and deployed user training for the Nonconformance and CAPA systems, Root Cause Analysis, and technical training for system administrators worldwide.Managed and developed documentation for upgrades and enhancements for the application to follow computerized systems validation methodologies including developing requirements, executing IQ/OQ, and PQ for Quality Systems Regulated software.Managed and maintained network security to comply with federal and state regulations.

Worked directly with record owners to conduct root cause analysis and complete CAPA records.Prepared and conducted monthly Nonconformance and CAPA meetings. Developed and deployed user training for the Nonconformance and CAPA systems, Root Cause Analysis, and technical training for system administrators worldwide.Managed and developed documentation for upgrades and enhancements for the application to follow computerized systems validation methodologies including developing requirements, executing IQ/OQ, and PQ for Quality Systems Regulated software.Managed and maintained network security to comply with federal and state regulations.

Worked on team to research, analyze, recommend, and implement corrective / preventive actions to external manufacturersand suppliers as a result of FDA audit observations and FDA warning letter. Activities included creating the SupplierRemediation Process, administering actions for Supplier Improvement Plans, and preparing documentation for FDA audit requests.

Managed and executed projects for upgrades to the Wastewater Treatment Plants of South Florida. Responsible for implementing structurally sound designs that met specifications and building code requirements.· Coordinated drafting changes and drawing uploads between Bogotá, sub-contractors, and Hollywood. · Managed and executed SCRWT-DB (South Central Regional Wastewater Treatment Plant Upgrades) Project · Provided design calculations for structures and specifications · Contribute to SMHWTP (South Miami Heights Water Treatment Plant), JEA (Jacksonville East Arlington Water Reclamation Facility), JEA (Jacksonville 1st Street and Main Street Water Reservoirs), and BCOES (Broward County Office of Environmental Services) Projects