KoalaT.ai

As a Freelance Project Manager, I specialize in regulatory compliance and quality management services for the medical device industry. My goal is to ensure that medical device companies achieve full compliance with FDA, ISO, and EU MDR regulations, while optimizing quality systems and operational efficiency.

Services Provided:

Regulatory Compliance Audits: Conduct comprehensive audits to evaluate and ensure compliance with FDA, ISO 13485:2016, and other relevant regulations.

Supplier Quality Management: Implement strategies to improve supplier performance, reduce costs, and enhance quality across the supply chain.

AI-Driven Compliance Solutions: Leverage AI technology to streamline compliance processes and provide data-driven insights for decision-making.

Process Optimization: Manage projects that optimize processes to improve efficiency and compliance readiness.

Flexible Engagement Options:
-Hourly Ad Hoc
-Short-Term Projects
-Long-Term Contractual Agreements (Remote or Onsite)

Industries Served:
-Medical Devices
-Pharmaceuticals
-In-Vitro Diagnostics

Specialized Audit Services:
FDA Mock Inspections
CAPA Management
ISO 13485:2016 Compliance
Supplier Audits
Quality System Audits (21 CFR Parts 820)
Multi-Country Registration & Approvals (US 510K, EU CE Mark)

Key Achievements:
Successfully reduced audit findings by up to 95% for multiple clients.
Developed and implemented AI-driven tools to optimize compliance processes, resulting in significant efficiency gains.

Contact Information:
If your organization needs expert guidance to navigate regulatory challenges and ensure quality compliance, feel free to connect with me here on LinkedIn or via email Neel@KoalaT.ai

Fractional Project Manager

Medtronic

• Led Audit Readiness program for Global Field Corrective Action (recalls) and Product Hold Order across four portfolios, enhancing audit preparation and execution.
• Collaborated with cross-functional teams to implement effective audit strategies, significantly reducing findings and ensuring compliance.

Enterprise Audit Readiness Program Manager

Endologix LLC

• Managed Supplier Change program to maintain supply chain continuity and oversee product lifecycle management
• Ensured design review, risk assessment, and control establishment in cross-functional teams
• Drove the completion of over 70+ supplier change evaluations and achieved EU MDR compliance
• Acted as front room SME during FDA, NSAI, ANVISA, and GMED audits and leveraged cross-functional SMEs in the backroom

Sr. Supplier Quality Engineer 

• Led cross-functional teams to complete Quality Impact Assessment, Component Qualification, and Supplier development
• Achieved design improvements, supplier changes, quality objectives, and supplier selection
• Led non-conformance investigations, and supported continuous improvement initiatives

Sr. Supplier Quality Engineer (Neurovascular)

Phillips-Medisize

• Implemented strategies for driving product quality and continuous improvement for Class I-III Medical Devices
• Developed CAPA documentation in partnership with suppliers, customers, and PMCM for effective root cause analysis and corrective action

Lead Supplier Quality Engineer

Alcon

•	Primary supplier quality contact for surgical consoles, PCB, and consumable product lines
•	Responsible project owner of supplier data analysis utilized in implementing updated Approved Supplier List (ASL) and retirement of suppliers in Supplier Review
•	Responsible for supplier’s qualification, assessment, review, and approval. Supplier surveys, Supplier Quality Risk Assessments, supplier certifications, first time buy approvals and Quality Agreements 
•	Provided Component Risk Assessments and verification by analysis for ultimate drawing updates in Engineering Change Notifications (ECN)
•	Provided assessment of dock to stock inspection data analysis of components 
•	Created and approved closure of quality notifications in SAP, gathered data regarding the supplier and the current inventory needing containment activities to ensure the production schedule could be met
•	Communicated Receiving Inspection & WIP defects to suppliers through the use of Supplier Action Request (SAR)/CAPA system
•	Completed training for basic auditor and (desktop) virtual auditing on Quality Management Systems to ensure conformance (ISO 9001 and 13485, CFR 21)
•	Responsible for project analyzing documentation, data, inspection, and drawings updates for safety critical components and compliance 
•	Resolved quality issues of capability, tolerance, and material related issues
•	Collaborated with suppliers, vendors, and teams of engineers to troubleshoot reoccurring nonconformances and safety critical issues 
•	Capable of managing large data and sharing statistical interpretation 
•	Experience with medical device production, process improvement and project management
•	Experience communicating with outside vendors and suppliers on cost contracts, technical drawings, production processes, and project needs
•	High understanding of team’s manufacturing and documentation process

Supplier Quality Engineer 

Chegg Inc.

• Assisted students with test taking tips and strategies. 
• Multitasked and prioritized independent work. 
• Tracked and analyzed student progress. 
• Communicated effectively with parents and staff.
• Helped students build knowledge on difficult topics such as preparing for SAT. SAT subject tests, and ACT as well as physics, chemistry, biology, biochemistry, and engineering.

Chegg Tutor

Torticollar (Sr. Design Project)

Slashed production costs from $2000 to $100 per unit.
Negotiated contracts with outside mass manufacturing suppliers.
Managed production, process improvement, prototyping, benchmarking, bench testing, 3-D printing, business team operation, as well as generated investor reports and presentations.
Investigated patent approval with medical patent lawyer consultation.

Quality Engineer / Research & Development		

University of California, Riverside Pediatric Rehabilitation Technology Lab

Using logistical models, conducted data analysis, obtaining measurements, performing study design and research methodology, as well as research-related activities, and initiating programming activities using MATLAB coding for examination of novel neuro-rehabilitation environments that aim to improve physical function and promote the development of children with motor disorders.

Research Assistant

Riverside Healthcare

Managed front desk, assisting patients with checking in, operating kiosks, and providing directions to various places within the facility. Also assisted with discharge and the transport of patients through the hospital and to their vehicles.

Volunteer

Program Manager | Supplier Management, Medical Device Auditor, AI

I help medical device startups and SMBs in the Midwest conquer FDA, ISO 13485, and EU MDR audits with confidence. 

I'm a certified Quality professional with 3+ years of experience building and optimizing compliant, efficient systems, specializing in:

Audit Readiness: Developing and implementing robust programs that streamline preparation and minimize findings.

Supplier Quality Management: Ensuring your suppliers meet the highest standards, reducing risk and improving your supply chain.

AI-Powered Solutions: Leveraging cutting-edge technology to enhance efficiency, provide data-driven insights, and create a proactive approach to compliance.

I have a proven track record of successfully leading projects that transform quality systems and deliver tangible results. 

For example, at a global medical device company, I spearheaded an enterprise-wide audit readiness program that reduced audit findings by over 95% while simultaneously supporting a remote Warning Letter re-inspection, ensuring a smooth and efficient process that led to the Warning Letter being lifted.

Building strong supplier relationships and navigating the complex regulatory landscape are also key areas where I excel. My data-driven approach, combined with a deep understanding of AI applications, allows me to solve complex problems and deliver solutions that directly impact your bottom line.

I hold multiple certifications in quality auditing (Certified Medical Device Auditor, Supplier Quality Professional, and Quality Auditor) and have a strong background in Biomedical Engineering (B.S.) and Technology & Innovation Management (M.S.). I've completed specialized coursework in AI in Healthcare & Biotech and Pharma from MIT Sloan School of Business, further enhancing my expertise in leveraging AI to solve real-world challenges in the medical device industry.

As a lifelong learner, I am dedicated to staying current with the latest trends, tools, and technologies, and sharing that knowledge with others. In my spare time, I enjoy testing AI devices and models, riding One-Wheel, home improvement, and producing electronic music.

If your medical device company needs a seasoned project manager who can step in and drive your critical projects to success, let’s connect.

I’m currently offering a complimentary discovery call to discuss how we can work together to streamline your projects, ensure compliance, and bring your life-saving technologies to market more efficiently.

Neelank Tiwari, MS, PMP

GPT Chain

The first automation engine built for chat interfaces. As n8n and ChatGPT had a genius baby! Let ChatGPT work for you 24/7.

Co-Founder

Makerpunks

We are a productized AI-first MVP agency. We help you build and launch your startup under 4 weeks for a fixed price.

Núcleo Lab

We grew a community with 100,000+ combined audience all around Latam. We focus on implementing AI and NoCode for companies. We worked with 20+ clients.

Notion

I created 130+ digital products for my personal brand, obtained 300,000+ downloads and grew a 70,000+ combined audience. I was featured in many sites like BGR, La Nación, El Comercio.

Notion Creator & Consultant

Nebulabs

Synthetic & experimental distribution channel built with AI systems optimized for email collection.

Torre

Growth Marketing Intern

Kaudal

Digital Marketing Intern

CIDE - PUCP

I was one of the teacher for the Fast Entrepreneur Training (FET) 2024. I was able to teach about nocode, automation and AI.

Teacher

Impact Startup Competition®

I was able to teach a group of entrepreneurs about nocode, ai tools and 3D printing.

Speaker

Migrante

I created a Digital Office Space for 3 different offices in different countries and a CRM system in Notion for a multi-region team of 200+ people.

Technical Consultant

A highly motivated and results-driven individual with a passion for technology and entrepreneurship. 

As a no-code developer, I specialize in Notion and Bardeen and have a proven track record of building successful brands, with over 350,000 downloads and 170,000 followers in under 3 years. 

I have extensive experience working with soonicorn startups, agencies, founders, and indie makers, and have served over 70,000 happy customers with my products and consultation services. 

My background in 3D printing, no code, and my current studies in International Business Administration have given me a unique perspective on business operations and strategy. 

I have a strong interest in automation and have been able to accomplish a lot through no-code development. 

I have successfully launched 25 products that have reached the top 5 of the day on Product Hunt and have received over 7,000 upvotes on my products. 

I am a lifelong learner and have acquired a wide range of skills through self-study and experience, including no code, automation, AI, project management, design, digital marketing, and sales. 

I am eager to continue growing and developing my skills and am always looking for new opportunities to make an impact and drive business growth.

Ignacio Velásquez Franco

Que hermoso que es construir tecnología 🖤

Este fin de semana nos encerramos 24 horas durante la IA Hackathon Peru 2025 para crear Paqa AI, un asistente de WhatsApp que almacena y analiza contenido que le gusta al usuario para generar nuevo contenido personalizado.

Algunas cosas que pasaron:

- Clasificamos a la final quedando en el top 5
- Conocimos builders apasionados y de talla
- Abrimos live con picos de 300 - 400 personas

Y aunque no ganamos esta vez, terminamos con un producto sólido, compartimos con los mejores del ecosistema y nos alimenta el alma builder 💪

Si te interesa más sobre nuestra solución estamos abriendo la herramienta al público general por solo 24 horas. Luego será por beta privada sólo para agencias o gestores de múltiples marcas.

👀 Demo: https://lnkd.in/eFitu82z
🔗 Web: https://lnkd.in/e-bV5UkC 
🦙 App: paqa.lat

Lo siguiente para nosotros es:

- Optimizar la plataforma en rendimiento y calidad de output
- Cerrar trato comercial con amiga creadora de contenido 
- Lanzar en Product Hunt

Podrás ver como monetizamos en vivo la herramienta. Aquí no dejamos que los repos se llenen de telarañas.

Finalmente...

Quiero agradecerle al team Javier, Daniel, Jose y Douglas. Son todos unos cracks y siento que esta experiencia nos ha unido muchísimo!

A los jurados Adrian, Martin, Sebastián, Gonzalo y Piero que también vivieron la hack en carne propia junto con los participantes.

A las organizaciones de AI PlayGrounds, Crafter Station, Makers Fellowship, START Lima y Universidad Peruana Cayetano Heredia.

Y a las personas detrás de todo Soledad, Jhonatan, Tomas, Anthony, Railly, Andrés, Cristian, Clarisa, Gustavo, Kate, Juan, Shiara y demás personas involucradas. Les quedo buenísimo, hacen algo hermoso por el ecosistema. 

El mismo Elon Musk lo dijo: 
"En un mundo en donde puedes obtener casi cualquier pieza digital por virtualmente nada, el activo más escaso son los eventos en vivo."

Y en serio, que lujo que fue esta hackathon! 🔥 
#IAHackathonPeru 🇵🇪

🚀 ¡Ya estoy dentro! 
Me registré para la IA Hackathon Peru 2025 🎯

Esta vez me junto con Javier, Daniel y Douglas como equipo para desarrollar una idea que revelaremos durante el evento 👀

📅 29-30 Nov | 📍 UPCH La Molina
💻 2 días de código, creatividad y soluciones con IA

Eventos como este me traen mucha nostalgia y recuerdos de la época en la cual todos los findes lanzaba en Product Hunt con mi avatar de patito (TheVeller) 🦆

La hack promete y muchísimo! 
Un enorme agradecimiento a los organizadores AI PlayGrounds, Crafter Station, Makers Fellowship 🔥

Tu landing profesional ya no puede depender “del amigo que sabe programar”😮‍💨

Voy a hacer una sesión en vivo donde construiremos una landing page profesional en Lovable, sin código, usando el mismo stack con el que hicimos:

🧠 victoryos.io 
🧪 makerpunks.dev 
🤖 nucleo.la 

La idea es que salgas con una buena base de tu landing y así empujarte (aunque no seas un perfil técnico) a lanzar o potenciar tu negocio usando IA y herramientas modernas:

- Prompts y copy claro en ChatGPT
- Landing limpia y lista para vender con Lovable
- Modelado 3D IA con Spline
- Componentes reutilizables con 21st.dev
- Imágenes y videos con IA con Freepik

📅 Día: Mañana, 18 de noviembre
🕖 Hora: 7:00 PM 🇵🇪🇨🇴 | 6:00 PM 🇲🇽 | 9:00 PM 🇨🇱

🔗 Registro: https://luma.com/eciqie0i

Vamos a diseñar como devs, pensando como dueños de negocio.
¡Ahí nos vemos, maker!

🚀 Cómo crear un GPT profesional — de idea a 500k conversaciones

Hoy, miércoles 12 de noviembre
📍 Modalidad: Online
🕢 Hora: 7:00 PM (hora Perú)

Basado en mi experiencia publicando 100+ GPTs y en uno que superó 500k conversaciones en menos de 48 horas.

Vamos a hacerlo simple y directo: te mostraré cómo pasar de una idea a un GPT profesional listo para publicar y escalar, trabajando con:

✅ Instrucciones y guardrails
✅ System prompt y herramientas
✅ UX, naming y señales de calidad
✅ Descubrimiento en GPT Store
✅ Distribución & oportunidades

Hoy veremos varios ejemplos propios y luego construiremos en vivo, desde cero.

¿El objetivo?
Crear y posicionar un GPT profesional que funcione como un “AI Wrapper” gratuito para atraer leads, vender lo que tu empresa ofrece y posicionarte en búsquedas dentro de LLMs.

Casos reales que mostraré:
• Ghibli Magic — de 0 → 500k+ conversaciones en 48 h
• Prompt Sequence Architect — GPT que genera automatizaciones para nuestro SaaS, GPT Chain
• Vibe Coding Prompt Architect — genera prompts de Vibe Coding y se conecta a un backend en n8n

Nada de bullshit: solo ejemplos propios, experiencia real.

Si eres creador, emprendedor, marketer, no-coder o simplemente quieres lanzar un GPT con estándar profesional sin depender de un equipo técnico, esta charla es para ti.

Nos vemos hoy.
Vamos a construir juntos.

Regístrate en el link de los comentarios👇

⚡ ¿Ya aprendiste a crear tu propio agente de IA?

Si no, esta noche es el mejor momento para hacerlo.

En un workshop 100% práctico, vas a construir tu primer agente automatizado con n8n, paso a paso.

🎙 Speaker: Javier Flores (CTO de Núcleo Lab)
📅 Hoy, 10 de noviembre
🕖 7:00 PM 🇵🇪🇨🇴 | 6:00 PM 🇲🇽 | 9:00 PM 🇨🇱

💡 Ideal si eres maker, emprendedor digital o creador que quiere usar la IA para automatizar procesos, ahorrar tiempo y escalar sin contratar más gente.

No necesitas experiencia técnica — solo curiosidad y ganas de construir algo útil.

🔗 Regístrate aquí: https://luma.com/uxyvgng9

¿Quieres crear ebooks profesionales en minutos?

Este miércoles 26 de noviembre vamos a hacer un workshop en vivo donde aprenderás a automatizar TODO el proceso usando:

⚡ Make: para recopilar, transformar y estructurar tu contenido.
❤️ Lovable: para generar diseños limpios, modernos y listos para entregar.

Vamos a construir un sistema completo que podrás reutilizar para tu marca, tus clientes o tus productos digitales.

📅 26 de noviembre
🕖 7:00 p.m. (🇵🇪)
🎙 Mayckol Cruzado - Community Builder en AI First Founders

🔗 Registro: https://luma.com/1yki4lbz

Este workshop es ideal para creadores digitales, agencias, instructores, marketers, emprendedores y cualquiera que quiera lanzar productos digitales más rápido.

¿El resultado?
Te vas con un sistema completo que podrás duplicar, adaptar y escalar para generar ebooks en minutos.

Nada de teoría. Nada de humo.
Solo sistemas reales que funcionan.

Nos vemos en el workshop. 🚀
Automatiza tu contenido. Construye más, trabaja menos.

¿Quieres una IA que de verdad entienda tu negocio y no solo repita prompts bonitos? 👀

En AI First Founders invitamos a Daniel Santos (Senior Data Engineer) a un workshop en vivo donde vas a ver, paso a paso, cómo implementar un RAG semántico con n8n & Supabase para que tus agentes trabajen con tu propia data y mantengan el contexto de cada conversación.

Te vas a llevar:
	•	Un flujo funcional en n8n conectado a una base vectorial en Supabase
	•	La lógica del RAG explicada sin humo
	•	Un blueprint para replicarlo luego en tus propios proyectos

📅 Mañana jueves 20 de noviembre
🕖 7:00 PM 🇵🇪🇨🇴 | 6:00 PM 🇲🇽 | 9:00 PM 🇨🇱
🔗 Registro: https://luma.com/rq57v9w1

Este es un workshop diseñado para pasar de jugar con prompts a construir sistemas serios.

🚀 ¡Ya estoy dentro! 

Me registré para JAKUMBRE 2025 – IV Cumbre de Emprendimiento e Innovación Universitaria 

Tres días para aprender, conectar y conocer de cerca cómo la innovación, la tecnología y el emprendimiento están transformando Arequipa y el Perú. 

Cada día se vive en una sede distinta, con enfoque en áreas clave del ecosistema:

📍 03 Dic | 9:00 AM – 12:00 PM
Paraninfo de la Facultad de Medicina UNSA
Área: Biomédicas

📍 04 Dic | 8:30 AM – 12:30 PM
Auditorio de Ingeniería de Materiales UNSA
Área: Ingenierías

📍 05 Dic | 8:30 AM – 1:20 PM
Hub JAKU Emprende UNSA
Área: Sociales

Arequipa necesita más eventos como estos, yo estaré allí, espero poderte ver también, de nosotros depende el éxito de nuestro ecosistema emprendedor. 

🔗 Registro (por día):
https://lnkd.in/euH26nTY

🗂️ Programa completo:
https://lnkd.in/eY5tkkqR

🌐 Organiza: JAKU Emprende UNSA + VRI + Parque Científico Tecnológico

Un especial agradecimiento al crack de Julio Lozano, traigamos más eventos a la ciudad! 

#JAKUMBRE2025 #UNSA #Arequipa

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The Battle

Neelank Tiwari, MS, PMP

Ignacio Velásquez Franco

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The Battle

Neelank Tiwari, MS, PMP

Ignacio Velásquez Franco

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Performance Score.css-goub6s{font-size:var(--chakra-fontSizes-md);font-weight:500;color:var(--chakra-colors-gray-600);display:block;margin-top:var(--chakra-space-1);}Ignacio Velásquez Franco's LinkedIn Performance

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