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 the R&D, Manufacturing and Quality Engineering functions on various Quality principles and their applications in product & process development

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 failure modes as it pertained to new design concepts  Provided guidance in the creation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols/ reports Responsible for the development and execution of Process Qualification (PQ) and Product Performance Qualification (PPQ) protocols/ reports Developed inspection & Test Method (TM) qualifications to assess the conformance and performance of electronic devices during Design Verification Testing (DVT), also responsible for the validation of TM’s to be transferred into production Assisted R&D in creating TM’s to assess the performance and safety of implantable electronic devices based on the guidance of IEC-60601-1, 2 Supported Regulatory Affairs in addressing questions received from regulatory bodies regarding submissions  Responsible for managing the successful transfer of a design from development into the production environment Provides guidance and coaching to junior engineers on the governing principles of Quality Engineering as per ASQ

 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 commercializing new medical devices Assisted Operations and Manufacturing Engineering team in defining process control deliverables required to comply with ISO 13485 and CFR Part 820 when developing and commercializing new medical devices Accountable for insuring that the Design History File (DHF) was complete and all design/ tech review deliverables were adequately addressed before commercialization Performed Gauge R&Rs to assist Quality Control in the development and improvement of gauging methods and techniques Created inspection & test methods to support inspection requirements and test plans using various types of gages & test equipment  Maintained Design History Folder(s) to ensure content completion & accuracy  Responsible for compiling and analyzing the data provided at the Managers Review Lead product investigations to identify the root cause of failure modes and potential improvement opportunities  Applied Lean Manufacturing principals to revise the MRB Process to prioritize NCMRs and reduce disposition times

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 assessments Liaison between R&D and Operations when discussing design specifications and process efficiencies and capabilities Responsible for assessing product safety and efficacy from inception to commercialization, led mitigations as required per ISO 14971  Responsible for identifying continuous improvement opportunities and leading their implementation based on post market surveillance data Developed control plans to assist in the management and monitoring of process behavior and operator interaction

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 components  Liaison between R&D and Procurement in the identification, qualification and development of external manufacturing suppliers/ partners Responsible for creating MVP’s which consisted of IQ’s, OQ’s, PQ’s and PPQ protocols and reports for characterizing and assessing the capabilities of manufacturing equipment Liaison between R&D, Marketing and Operations to ensure that PPQ’s where executed in accordance to protocol requirements and that the net production quantities satisfied initial launch quantities on the date of commercialization

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 Trained and educated leadership and work teams on Lean Manufacturing applications

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 Developed and presented presentations to the Facility Executive team to communicate the status of the Lean Implementation Strategy

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 processes data used to identify continuing engineering improvement opportunities Developed Predictive Maintenance Programs that increased equipment availability by more than 15%  Designed and implemented an oil recovery system which recycled degraded cooking oil and, as a result, yielded a minimum of $1.2M annually in cost avoidance in raw material usage

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, increased yield by 30% and a 10% reduction in raw material scrap