Quintessa McFadden

I’m a Quality & Validation Engineer with 10+ years of experience in FDA-regulated industries (medical devices, pharmaceuticals, packaging). I specialize in creating compliant documentation and repeatable systems — URS, FS, IQ/OQ protocols, test scripts, CAPA investigations, risk management files, and process improvements.
Alongside my corporate work, I support small businesses, farms, and nonprofits (similar to my Calabash technical assistance work) by building operational systems, grant-ready documentation, workflows, and simple-but-effective tools that make their work easier, fundable, and scalable.
What I Can Help You With
1. Technical / Corporate Services
URS, FS, IQ/OQ/PQ protocols – creation, cleanup, or execution
Test scripts, traceability matrices, and discrepancy reports
CAPA writing, deviation/root cause analysis, risk assessments (FMEA)
SOPs, work instructions, validation reports
Quality management documentation aligned with FDA, ISO 13485, EU MDR, or internal QMS

2. Small Business & Side-Project Consulting (Calabash-Style)
Perfect for food entrepreneurs, urban farms, wellness startups, and community projects.
Setting up simple operational systems (intake forms, workflows, task trackers)
Creating grant-ready documentation: budgets, program descriptions, work plans
Writing or editing SOPs, training checklists, workshop outlines
Organizing business tasks, reporting templates, or team coordination systems
Turning your business process into something repeatable, presentable, and fundable

Why Work With Me
✔ I bridge the regulated corporate structure with practical small-business problem-solving
✔ I create clean, easy-to-follow documentation — not confusing paperwork
✔ I understand both side-hustle realities and compliance requirements
✔ You give me the mess — I turn it into a system you can actually use