Expert Witness — Quality Engineering, Recall & Product Liability.

Senior quality engineering expert for product liability, recall, and quality-system disputes. Cross-industry depositions, written reports, and trial testimony backed by 20+ years across medical devices, aerospace, and consumer goods.

Plaintiff & Defense Counsel — All Sides

Available for plaintiff and defense engagements, subject to conflict check. Preferred case profile: complex quality-system disputes where cross-industry experience and active federal recall data infrastructure provide signal.

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Plaintiff Product Liability Firms

Mass tort, single-plaintiff, and class-action consumer product cases. Particularly cases involving recall histories, manufacturer track-record patterns, and supplier quality failures.

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Defense Counsel for Manufacturers / Sellers

Defense engagements on product liability, recall, ISO non-conformance, and supplier-quality disputes. Senior QA judgment to counter plaintiff expert claims.

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Medical Device Litigation Teams

21 CFR Part 820 compliance disputes, ISO 13485 non-conformance cases, Design Controls (DHF / DMR / DHR) deficiency claims, FDA enforcement-related litigation.

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Insurance Defense & Subrogation

Product liability subrogation cases for property & casualty insurers; insurance defense for product manufacturers and importers.

Categories of Cases & Engagement Deliverables

Cross-industry coverage with specific depth in medical devices, commercial / industrial equipment, and consumer goods.

Categories of Cases

What I Cover

  • Consumer product liability (CPSC-regulated products)
  • Medical device disputes — 510(k), Design Controls, 21 CFR Part 820 / ISO 13485 non-conformance
  • Commercial / industrial equipment failures (ice machines, food-service equipment, medical equipment)
  • Supplier quality and contract-quality disputes (US/China sourcing experience)
  • ISO non-conformance and certification disputes (9001, 13485, 14001, OHSAS 18001)
  • Quality-system causation analysis in recall and post-recall litigation
  • FDA enforcement-related disputes (483, Warning Letters, consent decrees)

Hourly Rate, Per-Case Retainer

Industry-standard retainer model. Hourly rate scaled by engagement complexity, jurisdiction, and travel.

Engagement Structure

Hourly Rate · Per-Case Retainer

Standard expert-witness retainer model. Rates discussed during the initial case-fit call after conflict clearance.

  • Initial 30-minute case review & conflict check — no charge
  • Retainer required prior to engagement; terms negotiated per case
  • Hourly rate scaled by case complexity, jurisdiction, and travel
  • Travel and expedited scheduling priced separately
  • Expert reports billed against retainer at hourly rate
  • Available for both plaintiff and defense engagements (single-side per case)

What I Don't Cover

Honest scope. If your case touches one of these areas, I'm not the right expert — and I'll tell you so on the first call.

Out of Scope:

  • Pharmaceutical / drug litigation. Not active in pharma cases. Refer to a registered pharmaceutical QA expert.
  • Pure software / cybersecurity disputes. Quality engineering scope is physical / hardware / regulated-physical-product.
  • Regulatory law expert testimony. Work alongside qualified counsel — I provide quality-engineering judgment, not legal opinion.
  • Single-side ethical conflicts. Once retained for a side in a case, will not consult or testify for the opposing side in the same matter.
  • Pure economic-damages analysis. Not a damages expert — refer for separate retention.

Senior Quality Engineer on the Stand

One person, on every report. No firm rotation, no junior associates drafting the testimony.

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Mark Mayeux
Quality Engineer · QESaaS

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. Director of Quality at Anatomy Supply Partners (US/China medical device sourcing, 2012–2015) and Scotsman Ice Systems (Ali Group subsidiary, 2016–2017). Past supplier-quality auditor across medical consumables, medical devices, and consumer goods.

ISO 9001 / 13485 / 14001 / OHSAS 18001 audit lead. 21 CFR Part 820 (FDA QSR), 21 CFR Part 11 (electronic records), cGMP, and Design Control (DHF / DMR / DHR) experience. Built the quality department at a medical equipment startup from scratch — company was later acquired. Also operates daily-running federal recall data pipelines (CPSC, FDA, USDA, NHTSA), useful for case-discovery work in recall-driven litigation.

21 CFR Part 820 ISO 13485 ISO 9001 / 14001 OHSAS 18001 Design Controls Six Sigma Supplier Quality Auditing Med Equipment Startup → Acquisition Federal Recall Data

Before You Inquire

Are you available for plaintiff or defense?

Both, subject to conflict check. Once retained for a side in a given case, I will not consult or testify for the opposing side in that same matter. I'll typically run an initial conflict check before any substantive case discussion.

Have you been deposed before?

I'm happy to discuss prior engagement history during the initial scoping call (under appropriate confidentiality). For new attorneys evaluating whether the credential matches the case, I can provide a CV, list of relevant past industry roles, and the methodology document at the-qa-audit.html.

What jurisdictions?

Available for federal and state engagements throughout the United States. Travel and lodging billed separately. Remote depositions accommodated.

How do you handle Daubert / Rule 702 challenges?

The QA Audit Methodology is published at the-qa-audit.html — it's a documented, repeatable framework that's been applied to every consumer product evaluation and every Pre-Launch Audit engagement under this practice. Expert reports cite the methodology directly. The federal recall data sources (CPSC, FDA, USDA, NHTSA) are public-record government databases.

How fast can you turn around an expert report?

Standard turnaround for a written report is 4–6 weeks from retainer + complete document production. Expedited turnaround (under 4 weeks) is available with appropriate rate adjustment. Initial case-fit review and conflict check typically within 48 hours of inquiry.

What kinds of recall-data analysis can you provide?

Live federal recall pipelines (CPSC / FDA / USDA / NHTSA, daily refresh) enable case-relevant queries that take days or weeks through public search interfaces. Examples: every CPSC recall on a specific manufacturer over 5+ years, all FDA recalls in a specific device category, manufacturer-level pattern analysis across multiple agencies. Useful for both plaintiff discovery and defense rebuttal.

Inquire About a Case

Initial 30-minute case review and conflict check is free. Book a slot directly or email — either way you'll have a response within 48 hours.