Hire the Best ISO 9001 Specialists
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Jesse H.

Houston, Texas

$70/hr
5.0
28 jobs

Unleash AI. Keep the leash. I write policies and procedures, build compliance frameworks, and develop AI-powered products for companies in regulated industries. GDPR. HIPAA. ISO 9001. ISO 27001. FDA 21 CFR Part 11. When AI enters the picture I layer in governance frameworks, privacy policies, & purpose-built agents trained on domain knowledge - not generic demos. 27 years in regulated industries. 300+ templates. 75-90% faster than traditional consulting using my trademarked AAIG methodology. I am not a consultant who says "no." I find the "yes, if we do it this way" path that lets you move fast and stay compliant. WHAT I BUILD Policies, Procedures, & Quality Management. SOPs, quality manuals, work instructions, and complete QMS builds. ISO 9001/27001/42001 from gap assessment through certification readiness. Audit preparation, corrective action workflows, and management review packages. Rebuilt an entire QMS for a global clinical trials platform - zero audit findings. Privacy Policies, Terms of Service, and Legal Compliance Documents. GDPR-compliant privacy policies, terms of service, cookie policies, data processing agreements, sub-processor agreements, consent frameworks, and data subject rights implementation. Fixed 7 live GDPR violations for an AI meeting platform. Built Django deletion workflows for right-to-erasure compliance. Global consent matrices covering US, EU, Canada, and Asia-Pacific. AI Compliance and Risk Frameworks. EU AI Act roadmaps. ISO 42001. NIST AI RMF. HIPAA Security Risk Analyses. Privacy impact assessments for GDPR, CCPA, and Colorado AI Act. GxP validation and 21 CFR Part 11 compliance for healthcare AI. Built Resilience AI Suite for a commercial client serving business continuity and IT disaster recovery professionals at U.S. financial institutions. Each agent follows a proprietary 9-section architecture with 32+ regulatory frameworks, SR 11-7 status assessments, and quality gates averaging 73 to 121 checkboxes per agent. Prompt sizes ranged from 79,000 . AI-Powered Product Development. Built a complete business operating system for REMVER Consulting - 230+ deliverables across 10 domains. First-to-market AI Disruption Readiness Toolkit for BC/ITDR professionals. Enterprise Document Drafter Agent Suite replacing $50K-$500K/year BC software platforms. Datasheets, implementation guides, landing pages, and full sales funnel architecture. Content, Courses, & Books. 48,000-word KDP reference book. 12 Udemy courses with slide decks and speaker notes. Synthesia video content. Two published books on AI governance. Full enablement ecosystem, not just the framework. National Government AI Governance Frameworks. Developed the AI Governance Framework for the Republic of Liberia integrating NIST AI RMF, OECD, UNESCO, EU AI Act, and African Union standards. Training packages, implementation roadmaps, and stakeholder consultation for national deployment. RECENT CLIENT WORK REMVER Consulting - Complete business operating system, AI products, book, courses, GoHighLevel bots, Synthesia videos. Financial services operational resilience aligned with OCC, FDIC, FRB, FFIEC. Clineca - Full compliance architecture for AI-powered clinical trials EDC platform. EU AI Act, ISO 42001, HIPAA, GDPR, GxP. Delivered 75% faster than Big 4. Invite Ellie - GDPR/privacy framework for AI meeting assistant. Privacy policy audit (7 corrections), Django deletion workflows, Visual Capture Compliance Framework. Liberia Telecommunications Authority - National AI governance framework for government deployment. EU AI Act Startup Toolkit - Turnkey compliance toolkit on 48-hour turnaround with automated risk scoring (83 formulas). THE FOUNDATION 27 years in regulated industries. Fortune 500: Alcon/Novartis (8 years, 200+ projects), Gilead, Genzyme, Pfizer, Baxter. Zero audit findings. Consent decree and FDA regulatory action leadership. MS Operations and Project Management. PMP certified 20 years. Contributing author, The FDA Group Newsletter (10,000+ executives). Published author of two books on AI governance. 300+ templates covering EU AI Act, ISO 42001, NIST AI RMF, ISO 27001, GDPR, CCPA, HIPAA, FDA 21 CFR Part 11, and Colorado AI Act. Every template refined through Fortune 500 implementations and delivered through 10-20+ iterations before handoff. WHO HIRES ME Companies needing SOPs, quality manuals, or ISO 9001/27001 implementation. AI startups needing privacy policies or compliance frameworks to launch. SaaS companies adding AI features needing GDPR, HIPAA, or EU AI Act compliance. Healthcare and clinical trials companies deploying AI. Financial services firms needing operational resilience tools. Companies that want AI agents or chatbots built with domain expertise baked in. Anyone needing enterprise-grade compliance without enterprise timelines or budgets. Engagement: Project-based consulting, fractional leadership, AI agent development, privacy & compliance documents, framework implementation. Global/Remote.

  • ISO 9001
  • AI Governance
  • GDPR
  • Data Privacy
  • HIPAA
  • ISO 27001
  • Regulatory Compliance
  • Risk Assessment
  • Policy Writing
  • AI Agent Development
  • Terms & Conditions
  • Technical Writing
  • Privacy Policy Writing
  • AI Policy
  • AI Compliance
  • Quality Assurance
  • Quality Audit
  • IT Compliance Audit
  • Project Management Professional
  • Project Management
Corinne F.

Napa, California

$65/hr
5.0
6 jobs

My career in workplace safety is built from a simple belief: safety should make sense to the people doing the work. After years working hands-on in manufacturing environments, I saw how often safety programs looked good on paper but failed on the floor. So I began consulting to help small businesses build systems that are clear, practical, and actually used. I provide HSE consulting and workplace safety support for small manufacturing and automotive companies, including: Safety policy and procedure development OSHA-aligned program creation and documentation Workplace safety audits and gap assessments Job hazard analyses (JHAs) ISO 9001, 14001, and 45001 Internal Audit / Compliance Guidance Training program development and custom training content SDS program organization and hazard communication support Incident review and corrective action planning Safety culture improvement strategy My focus isn’t just compliance — it’s clarity. I help owners and managers turn overwhelming regulatory requirements into organized, streamlined systems their teams can confidently follow. As my service offerings grow, I’m also integrating human-centered design principles into my work, with the long-term vision of building more intuitive, user-friendly workplace systems. Because safety shouldn’t live in a binder. It should live in how your business operates every day.

  • Safety Assessment
  • Safety Engineering
  • Workplace Safety & Health
  • ISO 14001
  • Training & Development
  • Policy Development
  • Ergonomics
  • Quality, Health, Safety & Environment Management
  • Program Management
  • Regulatory Compliance
  • Employee Training
  • Occupational Health
  • Facility Design
  • Environmental, Health & Safety Software
  • Management Consulting
  • User Experience
  • UX & UI Design
  • Human Factors Analysis
Alan B.

Bossier City, Arizona

$65/hr
5.0
6 jobs

I help organizations turn fragmented operations, recurring findings, and rough documentation into controlled systems that people can actually use. My work combines compliance system design, audit and risk infrastructure, SOP development, process documentation, manuals, policies, workflow design, and professional business documentation built for real operational use. Clients hire me when they need more than generic writing. They need structure, traceability, accountability, and documents that hold up under internal review, external scrutiny, and day to day execution. I work with organizations that need clearer operations, stronger document control, better audit readiness, more stable CAPA and risk processes, and practical documentation that teams can realistically follow. Core support areas include: 1. SOPs, work instructions, manuals, and policy documentation 2. Process mapping, workflow design, and execution frameworks 3. Internal audit structures, evidence logic, NCR and CAPA support 4. Risk registers, governance documentation, and management review inputs 5. Document control systems, revision logic, and controlled templates 6. Operational gap reviews and compliance aligned process improvement 7. Training materials, audit checklists, and implementation ready documentation 8. Technical and business document cleanup, refinement, and standardization My background comes from high accountability environments, including aviation maintenance, regulated operations, and audit exposed organizations where weak systems create safety, compliance, financial, and execution risk. That experience shapes how I build operational documentation: clear ownership, simple controls, usable structure, and adoption first design. I do not produce paperwork for its own sake. I build documentation and control structures that support consistency, visibility, repeatable quality, and stronger execution. Typical engagements include: 1. Reviewing current processes and identifying execution or control gaps 2. Designing end to end SOPs and workflow documentation 3. Translating quality, regulatory, or governance requirements into practical operations 4. Building document sets that support onboarding, control, and auditability 5. Strengthening risk, audit, and corrective action frameworks through better structure and documentation Industry depth includes aerospace, defense, regulated manufacturing, and other high compliance environments, but my documentation and governance models are transferable across organizations that need stronger operational control. To get started, send your current documents, rough notes, workflow pain points, audit concerns, or project objectives. I can review the material, define the scope, and recommend the best structure before drafting or redesign begins.

  • ISO 9001
  • Procedure Development
  • Technical Writing
  • Process Documentation
  • Instruction Manual
  • Digital Project Management
  • Operations Management Software
  • HR & Business Services
  • Risk Assessment
  • Content Writing
  • Quality Management System
  • Workplace Safety & Health
  • ISO 14001
  • Writing
  • Technical Documentation
Dereck W.

Las Vegas, Nevada

$125/hr
4.8
34 jobs

I am a seasoned Manufacturing, Quality, and Operations leader with a proven record of transforming organizations in aerospace, defense, and medical device industries. I specialize in building compliant, scalable, and profitable systems that enable companies to achieve certification, improve throughput, reduce cost, and strengthen customer confidence. I bring a rare blend of hands-on technical expertise, executive-level leadership, and real manufacturing ownership experience. I have successfully launched new production facilities, recovered at-risk operations from near closure, and led businesses to double and triple year-over-year growth. I understand the realities of running a manufacturing company—quoting, training, compliance, capacity planning, customer pressure, and profitability—because I have lived it firsthand. Clients hire me when they need practical, no-nonsense solutions, not theory. I eliminate waste, simplify processes, and implement systems that work on the shop floor, not just on paper. My reputation is built on delivering measurable results, clear communication, and a high-accountability consulting style that ensures projects exceed expectations. If you need support developing a Quality Management System, achieving AS9100/ISO certification, improving efficiency, or leading a high--impact improvement initiative, I will help you execute with speed, clarity, and excellence. Core Expertise Quality Management Systems & Compliance • ISO 9001, AS9100, ISO 13485, IATF16949 implementation • Internal Audits, Supplier Audits, Certification readiness & support • APQP, PPAP, FAI, IQ/OQ/PQ, Control Plans, FMEA • Corrective Action & Root Cause (8D, 5-Why), Risk Management Lean Manufacturing & Operational Excellence • Lean Kaizen, Gemba, Standardized Work, 5S, VSM, RIEs • Throughput improvement, waste elimination, capacity optimization • KPI & performance dashboard development • Policy deployment, visual management, training programs Leadership & Strategic Growth • Fractional Quality Manager / Operations Manager • Organizational alignment, strategic planning, scalable systems • Turnarounds and rapid improvement programs • Business expansion, cost reduction, and revenue growth strategies Engineering & Technical Capabilities • Mechanical & design engineering, CNC machining, CAD/CAM • Process development, metrology, GD&T, tooling & fixturing • Data analysis, statistics, Excel/VBA automation • Additive manufacturing, molding, forging, and foundry expertise Why Clients Choose Me ✔ Experience leading and owning real manufacturing companies — not just consulting ✔ Practical solutions that simplify operations, reduce costs, and improve compliance ✔ Deep industry expertise across aerospace, defense, automotive, and medical device ✔ Formal certifications: AS9100 Lead Auditor, Lean Six Sigma Black Belt, BSME ✔ High-touch, high-accountability delivery model with consistent results Typical Engagements • Build or upgrade QMS for certification (AS9100/ISO/IATF/ISO13485) • Fractional Quality or Operations leadership (10–40 hrs/month) • Lean transformation and throughput improvement programs • Audit preparation, internal audits, supplier audits • PPAP, FAI, and APQP support for OEMs and Tier suppliers • Process development, work instructions, and training programs

  • ISO 9001
  • ISO 9000
  • CNC Programming
  • Microsoft Excel
  • Quality Assurance
  • CAD Drafting
  • Lean Consulting
  • Welding
  • 3D Rendering
  • Business Development
Monica S.

Rancho Cucamonga, California

$50/hr
5.0
3 jobs

15+ years building quality systems—SOPs, procedures, and compliance—from scratch for 40+ small businesses in dietary supplement, cosmetics, tobacco and more. I’ve mastered FDA, NOP, SQF, and CDPH regs, leading 30+ audits and saving millions in fines. From FDA filings for food and supplements to EPA hazardous plans and ISO 9001 and ISO 22716 systems, I scope smart, cut costs, and deliver fast. AS9100 & ISO 9001 Lead Auditor Certified. As a regulatory consultant, I’ve turned non-compliance into wins—Organic Certs with NOP, rebuttals, updates, you name it. Need data managed or a system stood up quick? I’m your outsource expert—efficient, effective, compliant.

  • ISO 9001
  • Quality Management System
  • Good Manufacturing Practice
  • Internal Auditing
  • Internal Control
  • Internal Communications
  • Internal Reporting
  • Data Management
  • Manufacturing
  • Regulatory Compliance
  • Project Management
Dexter W.

Dallas, Texas

$65/hr
5.0
8 jobs

Based in Dallas–Fort Worth, Texas, I work with clients nationwide in two core areas: Real Estate Media and Workplace (OSHA) Safety Consulting. Real Estate Media - I help realtors and property owners showcase listings with clean, high-quality visuals that increase engagement and speed up sales. Services include: - Interior & exterior photography - FAA-licensed drone photography - Virtual staging & floor plans - Virtual tours & video walkthroughs - Fast turnaround with professional editing Instagram: @airlibrated Website: airlibrated.life Safety Consulting - I design company specific OSHA and ISO 45001 safety programs and deliver SCORM-ready training that can be deployed immediately in your LMS. Former EHS Leader at Boeing, Amazon, Panasonic/Tesla, Nuclear Power, and Carnival Cruise Line. What I deliver: - OSHA / ISO-aligned safety programs - Job-site safety - Incident, injury & near-miss reporting forms - Safety onboarding documentation - Contractor bidding assistance - LMS-ready safety training (SCORM 1.2 / 2004) with quizzes, tracking, and certificates Website: williamsconsultingfirm.life

  • Continuous Improvement
  • Leadership Development
  • Employee Engagement
  • Content Development
  • Instruction Manual
  • Construction Monitoring
  • Root Cause Analysis
  • Workplace Safety & Health
  • Procedure Development
  • Risk Assessment
  • Safety Assessment
  • Quality, Health, Safety & Environment Management
  • Occupational Health
  • Policy Writing
  • Strategy

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