Hire the Best Qcodo Specialists

Hi, I am a seasoned Regulatory & Quality Expert & Supply Chain Manager with 15+ yrs of experience in the medical device industry. I specialize in: 1) Quality / Regulatory consulting, NMPA, CE & FDA Regulations, Medical Device QMS, registration & submission; 2) Supplier qualification & management, product sourcing; 3) E-commerce operation/supply chain manager; 4) Project manager for NPD, cross-function project management; As a certified ISO 13485 Lead Auditor, Data Analyst, ASQ & RAPS member, and PMP holder, I bring expertise and reliability to every project. Let's work together to achieve your goals efficiently!

✅ 14+ years of Experience ✅ ISO Consultant (9001:2015/27001:2022/FSSC/FDA/UL-94-181/Food/HACCP/CCP/PRP's) ✅ Proven Results in ISO 9001, 27001, 14001, 45001, 22000, FSSC, SQF, 14064, 14065, 21001, 42001, ISO 51001:2024 ✅ISO 13485 and MDSAP-aligned Medical Device QMS readiness ✅ ISO AS9100D, EN9120 Specialist ✅ SOC 2 and CMMC Specialist ✅ CCPA/CPRA Compliance Specialist (Opt-Out Mechanisms, Data Sharing/Selling Controls) ✅ Legal and Regulatory Copywriter for Packaging Compliance ✅ Certified Quality Professional ✅ Secure SDLC & Privacy-by-Design Implementation ✅ ISO 14064-14065 Greenhouse Gas Emission (Certification & Accreditation) ✅ ISO 14064-1,14064-2,14064-3 (Verification and Validation) ✅ SAP S4/HANA QM Certified ✅ SQFI Implementation Expert ✅ Sustainability Data Management ✅ Internal Audit Expert ✅ Policy Writing ✅ SOP Specialist ✅ Company Policies and Procedures Manual ✅ Work Instruction & Checklist Draft Specialist ✅ FDA Regulations (Food, BRC, REACH, RoH) ✅ Data Visualization Expert ✅ Process Optimization Pro ✅ Process Mapping ✅ Document Control ✅ Manufacturing Data Specialist ✅ Virtual Assistance ✅ Operations & Process Structuring Consultant ⚡ Comprehensive Auditing: In-depth audits for ISO 9001 (Quality Management Systems) and ISO 27001 (Information Security Management Systems), ensuring compliance and identifying areas for improvement. ⚡ Customized Solutions: Tailored advice and strategies to meet your specific organizational needs, while aligning with international standards. ⚡ Continuous Improvement: Guidance on implementing best practices for ongoing quality and security enhancements. ⚡ Risk Management: Expert analysis and recommendations to mitigate risks, ensuring robust and resilient systems. ⚡ Training and Support: Providing staff training and support to understand and effectively implement ISO standards. 🚀Specialized Expertise🚀 in Quality Control, Assurance, and Audit Management across diverse sectors including manufacturing, healthcare, food, petrochemical, and automotive industries, I have consistently demonstrated leadership in achieving ISO 9001, BRC, ISO 27001, and ISO 14001 certifications. My proficiency extends to Data Visualization, where I leverage advanced techniques to drive insights and informed decision-making. In addition to my certification leadership, I have successfully spearheaded process safety initiatives and optimized business processes. My adeptness in SAP implementation and Quality Management (QM) ensures seamless operations and adherence to best practices. Furthermore, I possess a strong track record in complaint handling and process optimization. As an ISO Consultant and Writer, I am dedicated to crafting meticulous Policy & Procedure Documentation aligned with ISO standards, while ensuring full compliance with GDPR requirements. My commitment to excellence is evident in my punctual delivery and relentless pursuit of customer satisfaction, reinforced by consistently positive client feedback. In all my endeavors, I priorities not only quality and efficiency but also the safeguarding of data protection and privacy, thereby fostering trust and confidence in every project undertaken.

I help healthcare organizations reduce compliance risk, improve audit readiness, and streamline operations through structured HIPAA documentation, workflow design, and policy development. As a Healthcare Operations & Compliance Consultant, I specialize in translating complex regulatory and clinical requirements into clear, usable systems that teams can implement quickly and consistently. I’ve supported healthcare environments including specialty care and sleep medicine, with hands-on experience in documentation workflows, patient data handling, and compliance alignment. My work includes: • Policy and procedure development • Process documentation and workflow standardization • Clinical documentation review • Audit readiness support • Governance and board-ready materials • EHR workflow documentation With hands-on experience in healthcare operations and documentation oversight, I bring a systems-focused, evidence-based approach to every engagement. I identify gaps, standardize terminology, and organize complex information into usable frameworks that teams can implement and sustain. I deliver professional documentation and operational systems that support leadership, compliance, and measurable efficiency. Core Strengths • Healthcare operations & compliance • Audit readiness & documentation review • Policy alignment & process standardization • EHR workflow documentation • Governance materials & reporting • Structuring complex healthcare systems What You Can Expect Audit-ready documentation aligned with real clinical workflows Clear, structured policies your staff can actually follow Reduced compliance risk through standardized processes Fast turnaround with minimal oversight required Special Focus Areas: IntakeQ / PracticeQ setup & workflow optimization Clinical intake, documentation, and patient flow design Compliance workflow alignment (HIPAA, audit readiness) Identifying system gaps between intake, billing, and documentation SOPs that match real-world operations (not just policy requirements) I bring experience from healthcare operations roles including the VA and private practice settings.

🔹 STRATEGIC OPERATIONS, PROCESS TRANSFORMATION & BUSINESS SYSTEMS CONSULTANT I help founder-led and growing businesses improve operations, redesign business processes, implement scalable systems, and create the operational foundations needed for sustainable growth. With 20+ years of experience in business operations, process improvement, project delivery, and systems implementation, I help organizations move from reactive operations to structured, scalable operating systems. If your business is experiencing operational bottlenecks, inconsistent execution, poor visibility, disconnected systems, or founder dependency, I can help identify the root causes and implement practical solutions. What I Do I work with business owners, executives, and leadership teams to: ✅ Analyze and redesign business processes ✅ Build scalable operating systems ✅ Improve cross-functional workflows ✅ Implement business systems and operational infrastructure ✅ Design accountability and KPI frameworks ✅ Lead software and ERP implementation initiatives ✅ Develop SOPs, knowledge bases, and training systems ✅ Improve reporting, visibility, and decision-making My focus is not simply implementing software but improving how the business operates. CORE AREAS OF EXPERTISE Business Process Reengineering & Operational Excellence • Process Analysis & Improvement • Current State / Future State Design • Gap Analysis • Workflow Optimization • Organizational Process Design • Continuous Improvement • Change Management Business Systems Architecture • Operating System Design • Workflow Architecture • Business Requirements Gathering • Functional Specifications • SOP Development • Knowledge Management Systems • Onboarding & Training Frameworks Project & Implementation Leadership • ERP Implementations • CRM Implementations • Software Deployment • Stakeholder Management • Risk & Dependency Management • Cross-Functional Coordination • Vendor Management Performance Management & Reporting • KPI Development • Business Metrics • Executive Dashboards • Operational Reporting • Process Measurement • Accountability Systems AI & Automation Capabilities I help organizations leverage AI and automation where it creates measurable business value. Capabilities include: • Context Engineering • AI-Assisted Workflow Automation • Operational Knowledge Assistants • AI-Powered Reporting & Insights • Business Process Automation • Prompt Engineering for Business Operations • Workflow Intelligence & Process Audits • Automation Opportunity Assessments Tools include: ChatGPT | Microsoft Copilot | Google Gemini | Google NotebookLM | Zapier | AI Productivity Platforms PLATFORMS & SYSTEMS ERP / CRM • NetSuite (Admin & Project Management) | Odoo| Salesforce | Zoho | HubSpot Project & Workflow Management • Asana| Monday dot com | Trello | Jira | Avaza Process Mapping & Documentation • Lucidchart | Microsoft Visio | Notion Business Intelligence & Analysis • Excel | Google Sheets | Reporting & KPI Systems PROFESSIONAL BACKGROUND ✔ 20+ years in business operations, strategy, and project delivery ✔ 14+ years in senior leadership and operational management ✔ MBA - United States – Business Process Reengineering & General Management ✔ Bachelor of Science – Computer Science ✔ $100K+ Earned on Upwork ✔ 100% Job Success Score ✔ Top Rated Plus CERTIFICATIONS & EXECUTIVE TRAINING • Generative AI for Project Managers – IBM (2026) - Generative AI: Introduction and Applications - Generative AI: Prompt Engineering - Generative AI: Unleash Your Project Management Potential • Managing Projects in Notion – Coursera Project Network (2025) • Business Metrics for Data-Driven Companies – Duke University (2025) • Use RACI Charts for Work Management with Asana – Coursera Project Network (2025) • Improve Efficiency in Asana for Project Managers – Coursera Project Network (2025) • AI for Everyone – DeepLearning.ai (2024) • Oracle NetSuite Partner SuiteSuccess Methodology – Oracle University (2024) • Jira Fundamentals Training – Atlassian (2024) • Managing the Company of the Future – University of London (2022) • Design Thinking for Innovation – University of Virginia Darden (2022) • Digital Transformation – Boston Consulting Group (2021) 💡 Whether you’re implementing a new system, redesigning a business process, scaling operations, or building a more structured operating model, I can help turn complexity into clarity and execution.

I’m a Supply Chain and Demand Planning professional with 10+ years of experience supporting end-to-end operations from procurement and material planning to forecasting, inventory control, and supplier coordination. I help companies improve accuracy, efficiency, and on-time delivery through structured planning, analytics, and reliable execution. What I Can Do for You: ✔ Demand & Supply Forecasting ✔ Purchasing & Supplier Coordination ✔ Order Processing and Data Accuracy ✔ Inventory Management & Stock Monitoring ✔ Material Planning & Procurement ✔ Shipment Tracking, Lead-Time Monitoring ✔ Data Entry (ODOO, GDMI, GSCP, SCM systems) ✔ Report Preparation & Operations Support

I help SaaS companies, agencies, and government teams deliver complex technical projects on time — without the chaos. 15 years across Fortune 100 (Hewlett Packard Enterprise) and US government digital transformation (Granicus). At HPE I ran a multi-billion-dollar global portfolio across 150+ countries and cut deployment timelines by 20%. At Granicus I led public-sector digitization that changed how citizens reach essential services. On UpWork: 22+ projects · 5,000+ hours · 100% Job Success. I now operate as SOTO⟂DEV — a doctrine-driven technical practice for businesses that have outgrown chaos. Most automation and software breaks within a year because it was built to demo, not to last. I work the opposite way: documentation-first, maintainable by your team, designed to outlive the technology it runs on. What I deliver – End-to-end project management (discovery → UAT → rollout) for SaaS and public-sector engagements – Custom software & web apps — SaaS products, internal tooling, operational dashboards – Automation architecture (n8n, Make, custom) with runbooks your team can actually maintain – AI-assisted workflows (OpenAI, Anthropic) wired into your real CRM, not a toy demo – Chatwoot deployments — multi-inbox, multi-agent, white-label-ready – CRM optimization, SaaS operations, agile/sprint planning, cross-functional coordination – Fractional technical operator engagements for founders and ops leaders who need a steady hand How I work – Written scope before any code. Written handoff after. – Every system ships with a runbook, a recovery procedure, and a change log. – Stakeholder communication tuned for both engineering teams and executive audiences. – I optimize for the third year of the system, not the first week. Who I am Bilingual EN/ES, based in San José, Costa Rica (GMT-6). Available for US and EU time zones. Operating under a written doctrine — clients see it on day one, because the same standards that govern my code govern the engagement. If you need a senior operator who's done this at Fortune 100 and government scale, won't disappear on you, and ships systems built to last — let's talk.