Our Team at P Spence & Associates, LLC
About Ms. Penelope Spence - Quality Management System Consultant for Aerospace & Medical Device Companies
Helping Regulated Companies Build Audit-Ready, Risk-Based Quality Systems
Ms. Spence is a quality management system consultant specializing in aerospace and medical device industries. She helps companies build, improve, and sustain audit-ready Quality Management Systems (QMS) that meet the demands of AS9100, ISO 13485, and other regulatory standards.
Whether you need help preparing for a certification audit, remediating a CAPA, or strengthening supplier controls, Ms. Spence brings clarity, structure, and a practical approach tailored to how your business operates.
A Fresh Set of Eyes – With Deep Technical Expertise
With two decades of experience in regulated environments, Ms. Spence partners with clients as an independent, objective resource. She works closely with quality teams, engineering, and leadership to identify hidden risks, streamline documentation, and drive continuous improvement.
She brings a powerful blend of technical depth and real-world insight, grounded in dual Bachelor of Science degrees in Electrical and Computer Engineering from California State University, Chico. She also holds minors in Mathematics and Computer Science, equipping her to navigate complex systems with precision.
Areas of Expertise
- QMS consulting for AS9100 and ISO 13485
- Internal audit preparation and audit support
- CAPA development and root cause coaching
- Risk assessment and risk-based thinking implementation
- Supplier quality oversight and issue resolution
- Process improvement and nonconformance management
Problem Solving with Purpose
Ms. Spence is formally trained in Kepner-Tregoe Problem Solving and Decision Making, a structured approach to root cause analysis. She's also an active member of the American Society for Quality (ASQ) and continually sharpens her tools to stay ahead of industry expectations.
Her strength lies in helping teams understand why things to wrong - and how to fix them for good.
Why Clients Choose Ms. Spence
- Deep experience in regulated, high-stakes industries
- Hands-on approach with customized, non-cookie-cutter solutions
- Coaching style that empowers client teams
- Clear communication and practical deliverables
- Available for remote and on-site consulting across the US
"What works for one company may cause failure in another. I help clients find the right solution for the way they do business."
– Ms. Spence
When She's Not Improving Quality Systems...
Ms. Spence enjoys working out, meditating, cooking, and reading. She also spend lots of time with her rescue dog, Murphy – an energetic border-collie/lab mix who reminds her every day to stay curious and move with purpose.