Will Graham

About Will Graham

Will Graham brings over 25 years of experience in Quality Systems Development and Management. Will has extensive experience in development, implementation, and management of a variety of Quality Systems and Process Improvement initiatives in compliance with cGMP, ISO, TS, AS, and IEC standards / guidelines for Medical Devices, Biological Tissue, Automotive, and Aerospace products and testing requirements.At GQSI, Will has worked in Engineering extensively with Medical Device OEMs and Tier 1 Suppliers in various Equipment and Process Validations, including Program Management roles. She is responsible for design, development, and implementation of various IQ, OQ, PQ, POQ, PPQ, SQ, Process Characterizations, and Engineering Study requirements for Machining, Tooling, Manufacturing, Special Processes, Biological Tissue, Biological Cleaning, Testing / Inspection Equipment, and their related Processes. Will, also developed and implemented numerous PFMEA, Control Plan, and Gage R&R for Manufacturing Processes and Products. All of these requirements have met the mandated ISO, FDA, IEC, and/or CFR standards and regulations.Prior to GQSI, Will worked extensively in the Automotive and Laboratory Testing industry in various quality roles including Quality Engineer, Quality Manager, and Quality Director. Her roles varied amongst quality systems and process development, implementation, improvement, maintenance, and management. With major OEMs, she has interfaced continuously with Tier 1 and Tier 2 suppliers, including facilitating suppliers move from the “Bottom 25” quality systems to obtaining “Awarding Winning” quality achievements with OEM’s and National Quality Ranking Organizations.She holds a BS in Biology and Chemistry from University of MO, St. Louis, and is certified in various Quality Organizations. She also holds a Sigma Green Belt quality designation.

Experience

1. President

   Gqsi, Llc

   Jan 2016 — Present

   GQSI is totally committed to OEM and Supplier Quality Excellence with an unprecedented “VISION OF TOTAL QUALITY”. Our staff of seasoned Quality, Manufacturing Engineers, Operations, Laser Marking, Packaging, and Cleaning and Passivation, and Validation Engineering Services personnel are here to provide OEM and Tier 1 Supplier Product Service Support with a company philosophy that is apparent throughout our entire operation that “WE HELP MAKE GOOD THINGS BETTER”WEBSITE: AND ENGINEERING SERVICES:IQ, OQ, AND PQ PRODUCT, EQUIPMENT, AND PROCESS VALIDATIONMACHINING VALIDATION– MILLS, LATHES, EDM’S, AND ANCILLARY EQUIPMENTSPECIAL PROCESSES VALIDATION – HEAT TREAT, CMM, LASER, CITRIC AND NITRIC PASSIVATION FACILITIES VALIDATION – COMPRESSORS, HVAC, RO SYSTEMS, BOILERSFREEZERS, COOLERS, AND STORAGE CONTAINERSCLEANING VALIDATIONSTEMPERATURE MAPPINGCLEAN ROOM VALIDATIONANALYZE VALIDATION DATA, INVESTIGATE FAILURES AND CAPA’sMULTI-FACILITIES VALIDATIONPRODUCTS:MEDICAL AND BIOMEDICAL EQUIPMENT, INSTRUMENTS, AND DEVICES INCLUDING BIOLOGICAL HUMAN AND NON-HUMAN TISSUEOEM & TIER 1 SUPPLIER PRODUCT SERVICE SUPPORT:LASER MARKING – UDI AND TRADITIONAL LASER MARKINGINSPECTION AND PACKAGING – STERILE (CER) CLASS 8 CLEAN ROOM. AND NON-STERILE LABELING AND PACKAGINGCLEANING AND PASSIVATION INDUSTRIES: MEDICAL DEVICEBIOTECHNOLOGYPHARMACEUTICALCLINICALAVIATIONAUTOMOTIVEMILITARY AND GOVERNMENTISO 13485 AND 9001 CERTIFIEDNMSDC CERTIFIED MINORITY BUSINESS WOMAN OWNED BUSINESSMMBC: CERTIFIED SMALL BUSINESS ENTERPRISECERTIFIED MINORITY BUSINESS ENTERPRISECERTIFIED LOCAL SMALL BUSINESS ENTERPRISE - MEMPHISCERTIFIED DISADVANTAGED BUSINESS ENTERPRISE

Education

• University of Missouri-Saint Louis

  BS, Biology and Chemistry

Skills

• Spc
• Quality Assurance
• Iso 13485
• Apqp
• Quality System
• V&V
• Iso
• Process Simulation
• Sop
• Fda
• Dmaic
• Quality Control
• Gmp
• Minitab
• Six Sigma
• Quality Auditing
• Design of Experiments
• Manufacturing
• Fda Gmp
• Engineering
• Toyota Production System
• Root Cause Analysis
• Design Control
• Automotive
• Ts16949
• Research
• Validation
• Quality Management
• Medical Devices
• Capa
• Iso 9000
• Ppap
• Project Management
• Continuous Improvement
• Compliance
• Process Improvement
• Iso/Ts 16949
• Product Development
• Consulting
• Fmea