Fredrick S. Email & Phone Number

Santa Ana, California

Bartlett, TN

 Quality Subject Matter Expert (SME) responsible for supporting R&D initiatives related to the development and commercialization of Ear, Nose & Throat (ENT) devices Provides Design Assurance and Operational Quality support to the R&D and Manufacturing functions focused on design and process development and optimization Serves as a mentor and coach to.

Plano, Texas

 Project Manager responsible for delivering the Device Master Record (DMR) needed to consistently produce finished goods  Responsible for the development of Master Validation Plans (MVPs) and the draft of closeout reports (MVRs) Lead teams in developing the Process Failure Mode & Effects Analysis (pFMEA) document to assess & mitigate process related.

 Lead the Quality Assurance team to ensure that all departmental objectives were completed in a satisfactory and timely manner Developed and lead verification and validation strategies to evaluate product safety and efficacy and to assess process performance  Assisted R&D team in defining design control deliverables required when developing and.

Memphis, TN

 Responsible for the daily supervision of 2- Quality Specialist & 2- Quality Engineers  Partnered with Contract Manufacturers to build strategic relationships focused on achieving, sustaining & enhancing product quality requirements  Performed correlation studies to assess gauging errors when comparing supplier verification TMs/ TMVs to baseline.

Memphis, TN

 Project Leader on the commercialization of domestic and international product launches, responsible for on-time delivery, resource management, budgetary adherence and overall design transfer Partnered with Contract Manufacturers to build strategic relationships focused on achieving, sustaining & enhancing product quality requirements for purchased.

Memphis, TN

 Lead ~12 process excellence events which reduced changeover times by 50% and increased machine availability by 50% Analyzed manufacturing processes to identify opportunities to apply Lean Principles to improve manufacturing efficiencies Developed Future State Maps for targeted areas and developed action plans with timelines and expected benefits.

Southaven, MS

 Lead training sessions on Lean Enterprise principles such as 5S, Standard Work, SMED, One-Piece Flow and Visual Factory Lead process excellence project to eliminate the root cause of lost time injury claims by 50% which actually resulted in an 80% improvement Responsible for tracking the benefits realized as a result of completed Kaizen events.

Union City, TN

 Completed Lean Enterprise and Six Sigma Black Belt Training Mentored Green Belts and process owners on Six Sigma and Lean Manufacturing process and quality improvement principles and applications

Jackson, TN

 Lead reliability engineering efforts associated with the minimization of manufacturing downtime while maximizing equipment availability Responsible for the development and execution of all test protocols, i.e. IQ, OQ, PQ, Induced Failure Testing, Mean Time To Repair (MTTR) and Mean Time Between Failures (MTBF) Monitored and analyzed production.

Memphis, TN

 Manager of Sheet Metal Fabrication and Resistance Welding Operations in Microwave Oven Plant Responsible for an annual operational budget of ~ $4.5M Managed an Operational team consisting of 150 hourly and salaried associates in a union environment Implemented a cross training program which resulted in the reduction of lost time work injuries.