Trey Chelgren

Background

About Trey Chelgren

I bring a results-driven approach to manufacturing processes, combining technical expertise with a commitment to quality and compliance. With experience in optimizing and validating production workflows, I focus on delivering high-quality products while adhering to stringent regulatory standards, including FDA, ISO, GxP, and medical device-specific guidelines.Utilizing my green belt certification in Lean Six Sigma, I optimize methodologies to streamline operations and drive continuous improvement. From process validation to root cause analysis, I tackle challenges head-on, ensuring that every product meets the highest standards of performance, reliability, and safety. My skill set spans a variety of tools and techniques, including SolidWorks (CAD/CAM), Pro-E (CAD), Minitab, MS Excel/Project/Visio, Monday.com, and Master Control allowing me to implement data-driven improvements and solve complex manufacturing problems efficiently. I believe in including many levels of the organization when performing process development or root cause analysis as this improves the knowledge and teamwork of the organization resulting in a stronger organization and better solutions.With a deep understanding of regulatory frameworks, I have successfully ledand executed validation protocols for equipment, systems, and processes,ensuring compliance with FDA 210/820/1271, AATB, and ISO standards.In my time in management, I have hosted internal audits, AATB inspections, FDA assessments, and client audits to maintain operational readiness and uphold the highest level of quality assurance. I have experience with negotiating contractsKey strengths I bring to any organization include- Process Validation / Optimization Continuous Improvement - Root Cause Analysis and Problem Solving - Regulatory Compliance (FDA, ISO, GxP, AATB, GAMP, EU Annex 1)- Team Leadership and MentorshipI am passionate about applying my knowledge to improve processes, reduce costs, and contribute to the success of any organization. I am excited about new challenges where I can continue to innovate, optimize, and ensure that high standards of quality and compliance are met at every stage of production.#ProcessValidation #ContinuousImprovement #LeanSixSigma#ManufacturingExcellence