QESaaS is an independent quality engineering practice. Pre-Launch QA Audits, Expert Witness retainers, FDA 483 / Warning Letter Response packages, and ISO 13485 / 9001 audit prep — every engagement led by Mark Mayeux, a senior quality engineer with 20+ years across medical devices, aerospace, and consumer goods.
Most quality engineering consulting is open-ended: hourly billing, scope that drifts, six-figure engagements before the first useful deliverable. That's not how this practice runs.
Every service here is structured as a productized engagement with defined scope, defined deliverables, and a quote provided after a free scoping call. Senior cross-industry QA judgment is the asset; AI-accelerated research handles the data labor; the practitioner is on the byline.
The practice serves three audiences: small consumer-product brands launching new products, medical device firms responding to FDA enforcement actions or preparing for ISO certification, and litigation teams needing an experienced expert witness on quality-system, recall, and product-liability disputes.
Browse Services →Each service is built for a specific buyer with a specific deliverable. Click through for full scope, pricing, and engagement format.
For Amazon FBA, DTC, and Kickstarter brands launching new consumer products. Independent senior QA review — spec sheet, supplier docs, federal recall data check, risk-ranked findings. One-week turnaround. View →
For litigation teams on product liability, recall, and quality-system disputes. Senior cross-industry depositions, Rule 26 expert reports, and trial testimony. Plaintiff or defense, conflict-check first. View →
For medical device firms hit with FDA enforcement. Formal response drafting, CAPA plan against each cited observation, mock-audit before submission. Submitted on or before the 15-business-day deadline. View →
For quality directors preparing for ISO certification or recertification. External lead-auditor walks the QMS the way the registrar will. Gap report, written corrective-action plan, optional cert-day retainer. View →
One person, on the byline. No fictional staff, no rotating contractors — a senior quality engineer with two decades across regulated industries.
Twenty-plus years in product quality engineering across three categories where the cost of getting it wrong varies from ruined-your-Tuesday to ruined-your-life: medical devices, aerospace, and consumer goods. Same instinct, different stakes.
Director of Quality at Anatomy Supply Partners (2012–2015) — US/China medical device sourcing and supply company. Built the in-house Device Specification / FDA Regulatory team from scratch and ran 21 CFR Part 820 design control across US engineering and China manufacturing. Director of Quality at Scotsman Ice Systems (Ali Group subsidiary, 2016–2017) — passed major ISO 9001:2015 certification audits, multiple UL and FDA audits, plus customer-led supplier audits from McDonald's, GE, and Viking.
Earlier roles include performing supplier quality audits across medical consumables, medical devices, and consumer goods — and leading teams through years of ISO 9001, ISO 14001, and OHSAS 18001 certification audits, authoring company process documents and work instructions across every department. Mark also built the entire quality department at a medical equipment startup from scratch — hiring, agency documentation, supplier quality requirements, and supplier scoreboards — which was later acquired by a larger company.
Also operates federal recall data pipelines across CPSC, FDA, USDA, and NHTSA — built using AI as the labor layer. The same daily-running data feeds the QA Audit methodology, the Pre-Launch Audit service, and the manufacturer-reliability discovery work for expert-witness retainers.
The reasons clients choose this practice over a traditional consulting firm.
Every engagement has a written scope, written deliverables, and a quote provided before invoicing. No hourly drift, no surprise add-ons, no scope creep mid-engagement.
Mark personally owns every audit, report, response package, and deposition. No junior associates drafting the work, no firm rotations, no offshore handoffs.
Twenty-plus years across regulated industries. ISO 9001 / 13485 / 14001 / OHSAS 18001 audit lead. The credential isn't theoretical — it's verifiable through prior roles and customer-led audits passed.
The four operating commitments that apply to every Pre-Launch Audit, Expert Witness retainer, FDA 483 response, and ISO audit prep engagement.
No vendor referrals, no kickbacks, no preferred-supplier deals. Findings reflect what the documents and federal data actually show.
Twenty-plus years across regulated industries. ISO 9001 / 13485 / 14001 / OHSAS 18001 audit lead. Verifiable through prior roles and audits passed.
Written scope, written deliverables, quote provided before invoicing. No hourly drift, no surprise add-ons, no scope creep mid-engagement.
Mutual NDA available before any documents are shared. Engagement materials are not reused for other clients or published as case studies without consent.
Pre-Launch Audit, Expert Witness, FDA 483 Response, or ISO Audit Prep — initial scoping calls are free.