My name is Stephen Creech and I am a degreed Engineer in the field of Medical Device. My education consists of a bachelor's degree in Industrial Engineering with a Statistics Minor from North Carolina State University, and I have been in the Medical Device field for 28 years. Some of the largest and most successful Medical Device Companies in the world are on my resume, including Johnson and Johnson, Becton Dickinson, Zimmer Biomet, Teleflex Medical, and currently Viant Medical. My roles throughout the years have been in Production Quality Engineering, New Production Introduction, Supplier Quality Engineering, and Quality Management. Product experience of various types has been obtained in disposable labware, drug delivery, surgical devices, orthopedic implants, and orthopedic instruments. I have also obtained experience in various processes: Sterile Packaging, Injection Molding, Extrusion, Machining, Ultrasonic Cleaning, Passivation, Radio Frequency Welding, Laser Welding, and Laser Etching. I have led multiple projects and project teams to success ranging from million dollar process transfers to greater than 50% reductions in non-conformances. Management of successful teams of Engineers and Technicians ranging from five to as many as thirty-three employees at any given time is also in my repertoire. My certifications include Six Sigma Black Belt, Project Manager, and Validation Trainer and Practitioner. I have also completed training in multiple Lean principles including TWI, Kamishibai, and the Toyota Way. A wealth of experience has also been achieved in internal and external auditing both in application as well as on the receiving end. Standards experienced with are 21CFR820, MDSAP, ISO13485, and ISO9000. I have fulfilled the roles of SME, Back Room Lead, and Front Room Lead in multiple FDA, ISO, and Supplier audits. My career goals are to be a Quality Assurance leader within an organization that excels to be world class with opportunities to lead projects and teams to contribute to significant positive performance for the business as well as individual development.