Independent quality engineering services from a 20-year senior QA engineer. Fixed-scope, fixed-price engagements for small consumer product brands launching new products, medical device firms responding to FDA enforcement, quality directors preparing for ISO certification, and litigation teams needing an experienced expert witness.
Fixed scope, fixed price, written deliverables. No hourly billing, no scope creep, no six-month engagements before first results.
Independent senior QA review of a consumer product before it ships — spec sheet, supplier docs, recall-data check, risk-ranked findings. One-week turnaround.
Quality engineering expert for product liability, recall, and quality-system disputes. Senior cross-industry depositions, written reports, and trial testimony.
Just received a 483 or Warning Letter? Formal response drafting, CAPA plan, and remediation oversight — submitted on or before your 15-business-day deadline.
External lead-auditor walks your QMS the way the registrar will. Gap report, corrective-action plan, optional retainer through the cert visit.
Twenty-plus years in product quality engineering across medical devices, aerospace, and consumer goods. ISO 9001, ISO 13485, ISO 14001, and OHSAS 18001 audit lead. Past supplier-quality auditor across categories. Director of Quality at Anatomy Supply Partners (US/China medical device sourcing) and Scotsman Ice Systems (Ali Group subsidiary, passed McDonald's, GE, and Viking customer audits).
Built the entire quality department at a medical equipment startup from scratch — agency documentation, supplier scoreboards, US/China cross-border QMS — which was later acquired by a larger company.
Our 10-point quality engineering framework — applied to every Pre-Launch Audit, every Expert Witness report, every ISO audit prep, every FDA 483 response. Read the methodology, the AI-vs-human split, and the federal data sources before you decide whether to engage.
Read the Methodology →Each service is built for a specific buyer with a specific problem. Pick the page that matches what you came here looking for.
Launching a consumer product on Amazon, DTC, retail, or via crowdfunding? Get an independent senior QA review of your product before it ships.
View Pre-Launch Audit →Just received an FDA Form 483 or Warning Letter? Or preparing for an ISO 13485 cert / recert audit? Senior QA support with deadline-driven turnaround.
View FDA 483 Response →Plaintiff or defense counsel on a product liability, recall, or quality-system case? Cross-industry experienced expert witness available for retainer.
View Expert Witness →Initial scoping calls are free. Tell me what you're working on and I'll tell you whether the engagement is a fit — and if not, point you to someone better suited.