Technical Writing Portfolio
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Topics I Cover
FDA Compliance & Medical Device Regulations | Quality Management Systems (ISO 13485, QSR/QMSR) | Team Building | ITAR, CMMC & Cybersecurity for Defense Contractors | Lean Manufacturing & Continuous Improvement | Documentation Best Practices | Supplier Quality Management.
5 Signs Your Quality Management System Needs Modernization
*Quality Management Systems | ISO 13485 | Digital Transformation | Lean Manufacturing*
FDA Compliance & Medical Device Regulations | Quality Management Systems (ISO 13485, QSR/QMSR) | CMMC & Cybersecurity for Defense Contractors | Lean Manufacturing & Continuous Improvement | Documentation Best Practices | Supplier Quality Management.
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The Hidden Cost of Poor Documentation in GMP Environments
*GMP Documentation | FDA Compliance | Quality Systems | ROI Analysis*
Poor documentation costs regulated companies an average of $150,000 annually—not in fines, but in wasted time, repeated investigations, and quality issues that compound over time. This piece quantifies the real costs: investigation time that doubles, defect rates that climb from 1.2% to 2.8%, customer complaints that escalate into $27K incidents, and audit findings that multiply. Includes a framework for implementing Good Documentation Practices with an 800% ROI.
CMMC Compliance for Medical Device Manufacturers: A Practical Guide
*CMMC | Cybersecurity | Defense Contractors | NIST 800-171 | Medical Devices*
Medical device manufacturers entering defense contracting face a hidden challenge: CMMC compliance. This guide breaks down the 110 NIST 800-171 controls, explains implementation costs ($50K-150K), identifies common pitfalls (scope creep, AI tool risks, documentation burden), and provides a practical roadmap. Written from the perspective of someone who's implemented both ISO 13485 and CMMC—because understanding how they intersect is critical.
PFMEA Without Panic: A Practical Guide to Risk Analysis to Prevents Failures
*Risk Analysis | PFMEA | Process Controls | Process Improvement | Medical Devices*
Last month, I watched a team spend six hours completing a portion of a PFMEA. When I asked, "What will you do differently because of this analysis?" the room went silent. The spreadsheet had 87 rows. Every severity rating was 8 or 9. And three months later, the exact failure mode they "documented" showed up in production. PFMEA isn't supposed to be a compliance checkbox—it's supposed to prevent failures. Here's how to run risk analysis that actually works.
Why Your 8D CAPA Teams Keep Failing (And How to Build the Right Teams)
*CAPA | Team Building | Process Controls | Process Improvement | Medical Devices*
Your 8D team has seven people. They've held bi-weekly meetings over five weeks. They filled out all the forms. And they concluded with "operator error" and "additional training." Two months later, the same problem is back. This is why 8D teams fail: they're built for meetings, not problem-solving. Here's how to build teams that actually fix problems—starting with keeping them to 3-5 people.
When Your Calibration System Outgrows Excel: Managing Equipment Efficiently
*Calibration System | Process Controls | Equipment Verification | Medical Devices*
Tuesday morning, 7:45 AM. Our quality engineer opens the calibration spreadsheet—and realizes we've added 23 instruments since the last update. Due dates are wrong. Three gauges show past-due.
The FDA auditor arrives at 10 AM.
This is the calibration breaking point every growing manufacturer hits: Excel works at 20 instruments, barely manages 50, and collapses at 100.
Dedicated software costs $10-50K. But we cut our calibration coordination time in half, eliminated audit findings, and maintained compliance—all without buying software.
Here's the system that works.
The Delegation Gap: Why Doing It Yourself Is Costing You More Than Time
*Quality Management | Team Building | Leadership| Process Improvement | Medical Devices*
You just spent an hour completing a first article inspection that you could've delegated, while three strategic priorities are still waiting in your inbox.
Sound familiar?
Every Quality Manager faces this choice: do the work yourself (faster now) or teach someone else (sustainable later).
Most choose "faster now" and wonder why they're always the bottleneck.
I wrote about why the "efficiency" of doing it yourself is actually costing you strategic capacity, team development, and long-term scalability.