Quality System Audits
An Objective Eye on Your Quality System
Thorough, independent quality system audits for medical device and regulated manufacturers — grounded in ISO 13485, ISO 9001, and FDA requirements. Available remotely and on-site throughout Southern California.
Philosophy
Approach & Philosophy
“Too many times I have sat across from an auditor who wanted to ‘help’ me — or spent the bulk of every audit expounding on their experiences. That is not an audit. That is a consultation nobody asked for. It undermines the process, wastes everyone’s time, and leaves the organization without the honest picture they actually needed.”
— Amanda Barth, BSI Lead Auditor
My role is to provide an objective reflection of the state of your quality system — not to tell you how it should be done. That is what consulting is for.
I evaluate what I observe against the applicable standard, document findings with clarity and precision, and deliver a report that gives you an honest picture of where your system stands. What you do with it is up to you — though I am available separately as a consultant if you want help acting on the findings.
This approach protects the integrity of the audit, builds trust with your team, and gives leadership the unfiltered visibility they need to make informed decisions.
Audit vs. Consulting
Audit: Independent, objective evaluation. Findings documented against the standard — what was observed, not how to fix it.
Consulting: Hands-on guidance, system design, and remediation support — engaged separately to preserve audit independence.
Credentials
Certifications & Background
Certifications
Lead Auditor
ISO 13485:2016
BSI Group
Lead Auditor
ISO 9001:2015
BSI Group
Trained To
ISO 19011:2018
Auditing Guidelines
Background
6+ years inside regulated medical device environments — from QA/RA Associate to Quality Assurance Manager. Deep hands-on experience with ISO 13485, ISO 9001, FDA 21 CFR Part 820/QMSR, eQMS platforms, and audit-ready documentation practices.
Conducted and participated in quality system audits covering document control, complaints and returns, supplier qualification, design controls, lot release, production processes, and recordkeeping.
Led a compressed six-week ISO 13485 recertification drive at DynaFlex Technologies — including concurrent eQMS implementation and full quality system remediation under tight deadline pressure.
Get Started
Schedule an Audit
Fill out the form below and I will follow up within one business day to confirm scope and scheduling.