Trey Robbins

About Trey Robbins

Most operations leaders can run the machine. I build it. I am a manufacturing operations and quality leader committed to constructing the systems, infrastructure, and operational frameworks that take products from concept to commercialization and scale. With deep expertise in ISO 13485, Lean Six Sigma, design controls, and end-to-end product development, I focus on building what doesn\'t exist yet, and making it durable enough to grow on. Over eight years at a medical device startup, I built the operational foundation from the ground up, with no playbook, no inherited systems, and no room for error. That meant designing and launching an implant and instrument portfolio from CAD through regulatory clearance, standing up an ISO 13485-aligned QMS from scratch, implementing ERP and eQMS platforms with full KPI visibility, and deploying AI-powered audit tools that improved both speed and traceability. Every system I built was designed to outlast my involvement in it. My work bridges hands-on technical execution with operational strategy to strengthen quality systems, accelerate commercialization, and create infrastructure that scales. I bring together Lean and continuous improvement methodologies, data-driven decision making, cross-functional stage-gate program management, and deep regulatory fluency to deliver reliable, repeatable outcomes in high-stakes environments. I have led cross-functional teams across engineering, quality, production, and operations support, grounding my leadership in ownership, transparency, and a bias toward building rather than inheriting. I believe the best operational leaders don\'t just optimize what exists, they architect what\'s needed and make it run without them. What makes my background unusual is the combination of breadth and depth. I can read a CAD file, write an SOP, interpret a KPI dashboard, prep a regulatory submission, and present to leadership, in the same week. That full-stack operational ownership is rare at any level, and it\'s what I bring to the table. Core areas of focus include: ISO 13485 / FDA QSR compliance, audit readiness, CAPA Design controls, DHF/DMR documentation, V&V, IQ/OQ/PQ validation ERP/eQMS implementation, MES deployment, digital transformation Lean Six Sigma, continuous improvement, COPQ/OEE/FPY analytics End-to-end product development, stage-gate program management Cross-functional team leadership, change management, risk management Supplier quality, vertical integration, operational scaling

Experience

1. Senior Product Operations Manager

   Alevio Spine

   Jun 2019 — Present · Birmingham, AL, US

   I joined Alevio at an early stage to build the product engineering and quality infrastructure the company needed to bring its spinal implant portfolio from concept to market. My prior work at Integrated Medical Systems and The University of Alabama gave me the foundation, but this role let me do it for real: real products, real patients, real regulatory stakes. I\'ve built the systems that make this business run, from our ISO 13485 QMS and 510(k) submissions to our ERP implementation and manufacturing KPIs. What drives me is designing lean, scalable operations that produce high-quality outcomes and improve continuously as the business grows.Owned concept-to-launch programs across multiple regulated product lines; drove scope, scheduling, readiness checkpoints, and end-to-end delivery.Led cross-functional stakeholder management across engineering, quality/regulatory, suppliers, operations, and commercial teams to align priorities and keep programs on track.Supported multiple 510(k) submissions through clearance and market release; sustained audit readiness and led successful FDA audits.Implemented ERP/CRM systems and deployed an ISO 13485-aligned QMS; strengthened document control, traceability, and change control.Built an eQMS in Notion leveraging AI to accelerate SOP drafting, compliance checklists, and workflow triage.Developed a ChatGPT-based internal audit co-pilot for ISO 13485/14971 audit preparation (checklists, probe questions, traceability prompts, gap analysis).Created KPI visibility for manufacturing execution (FPY, RTY, COPQ, OEE, cycle time, scrap) and led Kaizen efforts based on measurable signals.Led investigations and corrective actions (NMR/CAR/CAPA), coordinating suppliers and internal teams to resolve quality issues without business interruption.

Education

• The University of Alabama

  Bachelor of Science , Business Administration, Management and Operations

  2017 — 2023

• WyoTech

  Associate of Science (A.S.), Automotive Engineering Technology/Technician

  2006 — 2008