We bring an engineer’s eye to your internal and supplier audits, spotting gaps others miss and understanding the technical side of your operations. We take ownership from planning through follow-up and make sure findings lead to real improvements, not just paperwork.
Every company runs differently, so we adapt to your systems while keeping you aligned with FDA, ISO, and other important regulatory expectations.
Internal & supplier audits
Our Services
We perform internal audits tailored to your organization's needs, whether against ISO 13485, ISO 9001, FDA 21 CFR Part 820, the new QMSR, or product-focused requirements.
What we do:
Audit QMS processes for compliance and effectiveness
Identify gaps in documentation, training, and procedures
Provide a comprehensive audit report with prioritized findings
(Optional) Support with corrective actions and CAPA closure if needed
Internal
Audits
We lead high-impact workshops that drive real change and align teams.
What we do:
Facilitate Kaizen events that eliminate waste and unlock efficiency
Lead Value Stream Mapping (VSM) sessions to improve flow and identify bottlenecks
Support production ramp planning and scale-up readiness
Drive cross-functional alignment between engineering, quality, and operations
Supplier
Audits
about us
Founder of StackSafe, Greg has over a decade of experience evaluating suppliers for technical capability, regulatory compliance, and operational excellence across industries like MedTech, aerospace, defense, and structural engineering. He has helped companies such as Boston Scientific, Outset Medical, UTC Aerospace, and General Dynamics streamline supply chains, enhance supplier performance, and solve complex quality challenges.
Greg holds a MicroMaster’s in Supply Chain Management from MIT, a Bachelor’s in Mechanical Engineering from North Dakota State University, and is a certified Six Sigma Green Belt. He also writes and speaks on topics like AI in MedTech, predictive inventory optimization, and compliance with global regulations, making him a trusted expert in supplier evaluation and operational strategy.
MicroMasters Program, Supply Chain Management
ISO 13485:2016 Lead Auditor Trained, PECB
AI Strategy and Governance Certificate
Six Sigma Green Belt
“I worked with Greg for a number of years conducting Quality System audits in the medical device industry. He is a thorough and detailed auditor. I would recommend him to perform technical audits/assessments for any company that needs to work and compete in a highly regulated industry.”
-James B.
“I highly recommend Greg for his exceptional skill implementing continuous improvement programs and processes in the healthcare industry. Greg has a strong understanding of breaking down large project roadmaps into individual deliverables and is very patient, explaining technical things clearly so everyone can understand. Because of his efforts, the processes are now smoother and more efficient. Greg was a real asset to our team.”
-Charlie L.
Recommendations
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Internal audits evaluate your company’s own processes and QMS compliance, while supplier audits assess your vendors’ ability to meet product and possibly ISO 13485/9001 requirements. Both are essential for identifying risks and ensuring compliance.
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ISO 13485/9001 and FDA 21 CFR Part 820 require suppliers to be re-evaluated periodically, with frequency based on risk. Critical suppliers are often evaluated every 12 to 24 months, while lower-risk suppliers may be on a longer cycle. Perform a risk mapping exercise to determine supplier risk.
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Independent auditors provide objectivity, technical expertise, and industry perspective. Engineering-led audits go beyond checklists- spotting gaps in design, operations, and compliance that internal teams may overlook.
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Findings are documented in a report and categorized by non-conformity. You’ll need to develop a corrective action plan, track progress, and verify effectiveness to close the finding. After auditing, we can help develop and implement corrective actions, track progress, and verify effectiveness to fully close the findings.