# Ramón B. Lopez

**LinkedIn:** https://www.linkedin.com/in/ramón-b-lopez-40b93b
**Email:** rblopeziv@gmail.com
**Location:** San Jose, California
**Relation:** James's brother and collaborator on qip-qien
**Slack user ID:** U0BDBR6K9KK

## Current role
**Sr. Director, Digital Manufacturing Architecture — Jabil** (July 2025 – Present)
- Owns strategy for modernizing PLM/QMS/LMS ecosystem across 100+ manufacturing sites
- Leading a $61.4M platform decision targeting 69–84% five-year cost savings
- Building a unified digital thread connecting design, change, quality, supplier, and training data

## Background (25+ years in medical device quality)

| Period | Role | Company |
|--------|------|---------|
| Jul 2025–Present | Sr. Director, Digital Manufacturing Architecture | Jabil |
| Jan 2020–Jan 2026 | Global Sr. Sector Director, Quality Systems | Jabil Healthcare |
| May 2016–Jan 2020 | Global Director, Quality Systems | BD Biosciences |
| Dec 2010–May 2016 | Sr. Manager, Quality Systems | Boston Scientific |
| Jan 2006–Nov 2010 | Analyst Principal, Quality Business Process Leader | Boston Scientific |
| Feb 1996–Jan 2006 | Analyst, SAP Functional Business | Novellus Systems / Lam Research |

## Core expertise
- **Digital QMS/PLM Transformation** — ETQ, Veeva, PTC Windchill, Siemens Teamcenter, SAP PLM, Propel
- **Regulatory compliance** — FDA, ISO 13485, EU MDR/IVDR, MDSAP; zero-finding audit track record
- **AI-Readiness for Quality** — data architecture, e-records/e-signatures, 21 CFR Part 11 environments
- **QMS at Scale** — launched QMS across 37 manufacturing sites during COVID, under budget, on time

## AI vision (directly relevant to qip-qien)
Ramón is actively positioning regulated manufacturers for:
- AI-driven change impact assessment
- Autonomous deviation detection
- Semantic data governance for AI agents in 21 CFR Part 11 environments

His framing: "Most quality leaders have deep regulatory compliance OR enterprise digital architecture. I have both."

## qip-qien connection
Ramón is essentially the *domain expert persona* qip-qien is built to serve:
- He works with factory production line managers daily
- He knows exactly what questions they ask and what context they need
- His 25 years of quality systems experience is the kind of institutional knowledge qip-qien routes tickets to
- His current AI focus (autonomous deviation detection, semantic QMS data) aligns with qip-qien's long-term vision

James is helping Ramón level up on AI and contributing to his GitHub repos. Ramón brings the domain depth; James brings the engineering and AI-native tooling.

## Open to
VP/Sr. Director of Digital Quality, Digital Transformation in regulated industries, or fractional CQO engagements.