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

RushTree

Strategic Business AI Optimization Services.  We increase clients revenue, profits and market share.  We Design and Deliver Practical, conversational AI Business Solutions.

Founder

tab32

Director of Strategic Accounts

Villa Sistemi Medicali - Radiology Ahead

Responsible for the company’s North & Central American operations, including strategic business development, implementing innovative growth strategies, and overseeing the company’s North American headquarters.  Disciplined execution on building a strong, client-focused, knowledge sharing, results driven organization. Leading teams to increase efficiency across all aspects of operations. In addition, maintains senior management responsibilities for sales, marketing, logistics, client care and daily operations.

Chief Operating Officer

TriState Dental Supplies & Equipment

Successfully implemented an innovative Business & Brand Development strategy.  Led company-wide 6-Sigma Performance Management System implementation.  Collaborated with senior management on upgrade of ERP & CRM systems.  Manage daily business functions with owners and senior management.

Vice President of Operations

Vatech America, Inc.

Managed sales, marketing, customer and technical support teams. Designed and implemented policy and strategy. Led company restructuring of sales force, reengineered marketing and client care department.

Focused team execution of pioneering strategy which spurred segment growth and created marketing strategy, which changed the direction of the industry. Sold majority of units sold in the Americas during tenure.

Vice President Sales & Marketing

Planmeca

Managed team of District Sales Managers. Developed and led team on execution of sales and marketing strategy. Redesigned business processes; provided real-time knowledge share and improved client experience. Developed successful dealer channels; trained dealer partner specialists nationally on consultative, clinically focused selling.

Eastern Regional Manager, US & CA (Re-Hire)

EdgeDent, LLC

Designed, launched and incubated innovative 3D/2D Digital Imaging and high tech dental office design dealer model. Produced significant sales for greater NY/NJ/CT region and captured over revenue. Grew worth of business with brand recognition for quality standards.

President

PSA, Inc.

Penetrated competitive NJ/Metro NY market with products and services. Served as point person for an established dealer network. Trained sales/service representatives and executed effective sales and marketing techniques to close business with dealer partners. Produced significant profit sharing for company partners for consecutive years.

Partner

Planmeca, Inc.

Built product support through persistent education, training, and support of product line to established dealer network and end users of high tech product line. Participated in extensive successful national trade shows and sales trainings. Generated consistent annual double-digit growth for tenure.

District Sales Manager

Eastman Kodak Co.

Performed stellar sales/technical support and customer service for Kodak and its dealer sales/technical teams and end-users.

Service and Sales Representative, HEALTHCARE-DENTAL PRODUCTS DIVISION

BUILDING BRANDS INTO MARKET PROMINENCE

As a dynamic AI business leader, I’ve strengthened brand positioning in highly competitive segments through devising solutions, creative growth initiatives and continuous improvement.  Solid management and leadership experience.  Over 20 years of remote work experience, including 5 years of remote team management. 

These capabilities combined with strong vision, strategy, general management and P&L skills have lead organizations to increased profitability and market share.

Known as an excellent communicator and influencer, I’ve cultivated internal and external partnerships to support long-term business viability.  

Additional areas of expertise include marketing strategy, business turnaround, and optimizing sales teams and organizational effectiveness.  

SPECIALTIES
♦ Sales and Marketing 
♦ Start-ups 
♦ Turnarounds 
♦ Premium Brand Building 
♦ Client Satisfaction 
♦ Strategic Market Planning 
♦ Relationship Management 
♦ Sales Force Re-engineering 
♦ Distribution
♦ New Product Development and Launch 
♦ Process Improvement 
♦ SaaS 
♦ 3D/2D Digital Imaging 
♦ TQM
♦ 6-Sigma
♦ Conversational AI
♦ 3D Printing

Paul Blocchi

This encouraging, insightful  post by  Dr. Martha Boeckenfeld reminds me that today’s ways usually aren’t the answer to a better tomorrow.  

If this post resonates, pass it on…

LED lights just killed 92% of cancer cells in 30 minutes. No chemotherapy. No radiation. Just light and tin oxide nanoflakes.

The healthy cells next door? Completely unharmed.

Think about that.

Every year, 10 million people endure chemotherapy that attacks their entire body to reach one tumor. Hair falls out. Organs suffer. Immune systems collapse. We've accepted this barbaric trade-off for decades—poison everything to save something.

Scientists just proved we don't have to.

Traditional Cancer Treatment:
↳ Chemotherapy poisons your whole body
↳ Radiation burns healthy tissue
↳ $150,000 average treatment cost
↳ Months of devastating side effects

The Light Revolution:
↳ LED light + tin oxide = targeted destruction
↳ 92% skin cancer cells eliminated in 30 minutes
↳ Zero damage to healthy cells
↳ Costs less than your phone charger

But here's what stopped me cold:
This isn't some million-dollar laser system. It's LED lights—the same technology in your desk lamp. The tin oxide nanoflakes act like tiny solar panels, converting light to heat only where cancer lives. Your tumor gets cooked. Your body stays cool.

Water-based. No toxic solvents. Scalable today.

What changes everything:
↳ Cancer clinics in rural villages
↳ Home treatments becoming possible
↳ No more choosing between cancer and quality of life
↳ Precision medicine for pennies, not fortunes

The Multiplication Effect:
1 LED device = one life saved without suffering
10 clinics equipped = chemotherapy wards emptying
100 countries adopting = cancer's cruelty obsolete
At scale = we stop fighting cancer with poison

Early results from clinical studies show extraordinary promise for cancers like skin, breast, and lung tumors, marking a potential revolution in oncology.

We spent 50 years perfecting ways to almost kill patients to cure them.
Now we're learning to heal with light.

Because when you can delete cancer cells like pressing a switch, you're not just treating disease.

You're deleting suffering from medicine itself.

Follow me, Dr. Martha Boeckenfeld for breakthroughs that make healing humane again.

♻️ Share if for people to learn more about new cancer treatments.

📄 RESEARCH PAPER
Jean Anne Incorvia et al., "SnOx Nanoflakes as Enhanced Near-Infrared Photothermal Therapy Agents Synthesized from Electrochemically Oxidized SnS2 Powders", ACS Nano (2025)

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The Battle

Neelank Tiwari, MS, PMP

Paul Blocchi

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taplio

The Battle

Neelank Tiwari, MS, PMP

Paul Blocchi

Followers

Posts

Engagements

Likes

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);}Paul Blocchi's LinkedIn Performance

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