Cheryl Franklin

About Cheryl Franklin

Principal Quality Engineer and CAPA program leader with 20+ years of experience driving quality systems, regulatory compliance, and cross‑functional execution across medical devices, pharmaceuticals, energy, and regulated manufacturing environments.I specialize in owning complex, enterprise CAPA programs end‑to‑end — from issue triage and investigation strategy through corrective action execution, effectiveness verification, and audit defense. My role is not to be the product or process SME, but to govern methodology, ensure investigation rigor, translate regulatory expectations into executable strategy, and hold teams accountable to outcomes.I am a trusted advisor to engineering, operations, and leadership teams for inspection readiness, risk‑based decision making, and audit‑defensible documentation. I routinely lead and support internal audits aligned to ISO 13485, MDSAP, ISO 9001, and FDA 21 CFR 820, and I develop training and tools that strengthen CAPA quality and consistency across organizations.Known for strategic thinking, calm execution under regulatory pressure, and disciplined program management, I bring structure to ambiguity and drive sustainable quality improvements without slowing the business.United States Navy Veteran | Certified Lead AuditorCore focus areas:CAPA Governance · Quality Systems · Regulatory Compliance · Audit Readiness · Root Cause Analysis · Risk‑Based Investigations · Project & Program Management · Cross‑Functional Leadership

Experience

1. Principal Quality Engineer

   Medtronic

   Oct 2024 — Present

   Principal Quality Engineer providing CAPA governance and quality systems leadership within a medical device operating unit. Lead and govern complex CAPA programs, including issue triage, investigation strategy, root cause analysis, corrective action planning, and effectiveness verification, ensuring activities are risk‑based, compliant, and audit‑ready. Drive improvements to CAPA rigor and consistency through development of standardized tools, training, and guidance, strengthening investigation quality and regulatory defensibility. Support internal audit and inspection readiness activities aligned to ISO 13485, MDSAP, and FDA 21 CFR 820, and develop quality metrics and KPI reporting to support data‑driven decision making. Recognized for translating regulatory expectations into practical quality system execution and influencing cross‑functional teams to deliver sustainable corrective actions without direct authority.

Education

• Ursuline High School

  College/University Preparatory and Advanced High School/Secondary Diploma Program

• The Ohio State University

  Chemical Engineering

• Youngstown State University

  Bachelors of Engineering , Chemical Engineering

Skills

• Petroleum
• Gas
• Project Management
• Chemical Engineering
• Management
• Engineering
• Veterans
• Project Engineering
• Process Engineering
• Manufacturing
• Six Sigma
• Public Speaking
• Lean Manufacturing
• Leadership
• Cross-Functional Team Leadership
• Energy
• Customer Service
• Product Development