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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 knowledge transfer during implementation and sustainability.

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, managing the response, investigation corrective action and sustainment of multiple audit findings resulting from internal system assessments. In addition, assuming additional responsibilities as the project progresses through the timeline.

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 mitigation corrections/containment, while ensuring cohesive root cause methodologies applied to drive effective and sustainable improvements. Interacted with internal and external personnel, including physicians and regulatory bodies, on technical matters and field issues. Provided Compliance Assessments of Clinical Assessments/Health Hazard Analysis, CAPA, and Nonconformance’s ensuring that the proper actions were taken regarding patient safety and Quality Compliance.

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 expertise challenges thru “Hands-On” deployment. Developed CAPA’s for all “at risk” CFR sub-sections assuming ownership of multiple CAPA’s while driving plan to closure. Effectively provided project management and mitigation expertise to complete all plan deliverables, on-time, 1st time right without indication of recurrence through scheduled milestone and Senior Leadership Team Reviews. Strategized Full Quality System Remediation Plan with Site Director in preparation for future activities.

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 system oversight. Consultant Team Lead for TUV, HPRA, and FDA CAPA Remediation Plans. Met all client timelines and deliverables while managing “day-to-day” operations. Notable accomplishments include developing a CAPA Business Unit Certification Program, creating a Standard Root Cause Investigation Tool Box. Standardized and automated KPI’s while reducing process variability through the development and implementation of Quick Reference Guides for procedures.

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 including current and future state processes. Addressed staff augmentation by implementing a Competency-based Training Program for the Litigation Field Assurance Group to accelerate new hires to a point of being process value-added. Mapped and authored a Service and Repair Divisional and Work Instruction Standard Operating Practices for the Field Assurance Group. Shored up knowledge weaknesses by developing and educating personnel on such topics as Work Flow Balance, Theory of Constraints, CFR 21 820 and 803 QSR, cGMP/GDP, and Process Standardization.

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 into the Global Vision Care. Managed Site Novartis Investigator Certification Program. Alcon/Novartis Corp. Recognition in Driving Continuous Improvements in CAPA Management.

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 development and implementation of remediation and mitigation plans. Provided surveillance of implementation to ensure sustainment. Site SME for Continuous Improvement activities including Track Wise CAPA Work Flow and Product Disposition.

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 Manufacturing. This included continuous improvement activities and Kaizen facilitation.

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