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Cambridge, Massachusetts, United States

QMS Remediation, Consultation, and Support.

Maryland, United States

EUMDR Project Manager supporting Class I & III products for Technical Documents and Design Dossier remediation to EUMDR requirements. Achieved Self-Certification for Class I and Notified Body Submission and review of MDR Checklist without Deviation.

Augusta, Ga.

Supporting Combination Drug Remediation through detailed gap assessment analysis, Risk Mitigation, and Remediation Project initiatives supporting compliance to 21 CFR 200 & 210. Primary focus relating to system developments for Annual Product Stability Testing and Sample Retention Programs. Specialized focus on 'right-sizing' processes to ensure ease in.

Augusta, Ga.

Providing Quality System Remediation Project support, both consultant and direct ownership of action items for the Augusta, GA. Manufacturing Site. The objective is to create an "Audit Ready" environment across the site. My responsibilities include the redesign and implementation of both Labeling Controls and Unplanned Maintenance activities. In addition.

Mansfield, MA.

Provided key technical expertise and leadership related to released product. Appropriately and strategically applied technical knowledge, tools, and methodologies to drive product quality. Developed innovative and effective solutions to technical problems. Guided successful completion of CAPA’s, from initiate nonconformance triage, defining effective risk.

Augusta, Ga.

Requested by the V.P. Quality Patient Monitoring and Recovery of Medtronic to support the Quality System Deployment Plan at the Augusta, GA. Medical Supplies Site. Managed the Deployment Plan, consisting of 89 multi-functional “improvement opportunities” via Agile PLM CAPA system via 6-Month implementation Plan. Mitigated both resource and subject matter.

Boulder, CO

Assumed interim Quality Compliance/CAPA Manager responsibilities for 9 manufacturing support and Design Sites within the Early Technologies and Respiratory & Monitoring Systems allowing department management to focus on resource allocation and off-site support. Reduced CAPA delinquency by 80% and recurrence by 90%through Champion mentoring, training, and.

Greater Atlanta Area

Provided Litigation Support during Quality System field action timelines. Developed Value Stream Maps of the Litigation And Field Assurance processes and identified improvements in the areas of efficiency gains, balanced flow, and KPI implementation. From the Map, developed capacity and resources allocation models for current and future production demands.

Duluth, Ga.

Managed the Duluth Site CAPA System. Achieved and sustained 100% on-time closure of CAPA System records without compromising robustness or efficiency the investigation/activity. Responsible for Vision Care Global and Site specific metrics. Provided CAPA SME support for Corporate initiatives in CAPA System harmonization/Integration of Alcon/Novartis systems.

Norcross, Ga.

Directed Quality Systems Engineering Group while overseeing management of the CAPA System. Managed an Investigation Team focused on CAPA related investigations including Manufacturing Investigations of Customer Complaints. Facilitated the use of DMAIC methodologies for advanced problem solving. Instrumental in all FDA/ISO responses including the.

Germantown, MD.

Managed Labeling Systems for multi-site locations. Provided Continuous Improvement support for Site by applying Kaizen methodologies to problematic areas. Co-managed improvements in product packaging refinement to meet customer expectations.

Dayton, Ohio Area - Beltsville, MD

Provided QMR support for the Dayton, Ohio Bio Life Plasma Center. Responsible for all quality System activities including Medical Records, Lab Test Results, material reconciliation, and shipments. Managed all local and internal audit activities while providing global support to division expansion.Provided Project Management support for Baxter Vaccines.

Bachelor'S Degree, Automated Manufacturing Engineering, 3.2

Theory, Applied, and Advanced robotics applications in Automated Manufacturing

Associate'S Degree, Electrical And Electronics Engineering, 2.9

Theory and Applied applications of Electronics and Electrical Engineering