Stephen Creech Email & Phone Number

Surgical Cuff project leader in outsourcing to international contract manufacturerFilled temporary role as Zimmer Surgical Program Manager from 6/10 to 12/10Kepner Tregoe certified in problem solving, decision making, and project managementStatesville remediation project leader for Surgical Cuff product lineValidation system remediation implementation for Surgical divisionCalibration improvement project lead in full implementation of GageTrak for Surgical division

Synthetic Wound Closure R&D and ManufacturingClass II and III medical device Product Development team support in Quality AssuranceFDA 483 corrective action implementation team leader for Omnex Internal Surgical SealantNCMR system improvement implementationNCMR and CAPA investigation support to Engineering and ManufacturingResponsible for QA metric development and dashboard presentationTrained in Six Sigma Design Excellence

Management of one Quality Engineering Technician and nine Quality Technicians responsible for the inspection and release of purchased finished goods.MRB member and integral decision-maker in non-conforming product disposition.Inspection reduction and elimination project leader and system developer.Responsible for inventory management and control of Quality inventory locations in multiple inventory management systems (PRMS (AS4000), QAD, and SAP).Quality support of the introduction of new purchased finished goods.Internal audit support of Teleflex Medical Manufacturing, R&D, Customer Service, and Product Complaint functions.Quality support of Pilling Surgical device transfer from Mfg. to purchased finished goods.

Advanced Drug Delivery - Pharmaceutical SystemsDesign Control and Quality Engineering Support to Hybrid Microinfusor ProjectMicroinfusor Measurement System Analysis SupportAdvanced Drug Delivery Inventory Database Development and Verification SupportResearch Catheter Set Real Time Product Stability EvaluationGlucose Control Algorithm Project Planner and Quality Engineering SupportAdvanced Drug Delivery Quality System MaintenanceProject Management Certified

Biosciences Discovery LabwareJuran Certified Blackbelt in Six Sigma Manufacturing and Greenbelt in 6* TransactionalCertified Validation Practitioner and TrainerIntegral support resource for new product and process introductionsCost avoidance of $150,000 or more per year from Six Sigma project leadershipCo-Trainer in Six Sigma methodology at the Greenbelt levelLed continuous improvement efforts in the Roller Bottle businessDirect customer interface domestically and internationally

Biosciences Discovery LabwareManagement of thirty-three team associates and three leadership representatives responsible for production, quality, cost, safety, engineering, and team developmentDirect customer interface regarding product improvements, sales, quality audits, and scheduling.

Biosciences Discovery LabwareAssisted in transfer of Tissue Culture Manufacturing from Sumter South Carolina to Durham North CarolinaDeveloped and introduced the Shrink Wrapped Packaging ProcessDesigned and implemented a class 10,000 clean roomCoordinated and performed molding (Injection and Blow) process and product validations Performed Bench Marking Studies to improve products and the marketing of those products Investigated and resolved Tissue Culture customer complaints Participated and led ISO and customer audits

Led trend analysis program: proactive monitoring of key quality characteristics, identification of trends, and assembling teams to determine the root cause and corrective actionsProvided statistical instruction for Engineers and Scientists at all levelsAssisted in failure investigations, validations, and the implementation of new products and processes in manufacturingQualified secondary suppliers and measurement equipment

Bs, Industrial Engineering

Post Baccalaureate, Studies

Design of Experiments, Statistical Process Control and Acceptance Sampling