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

Unleash The Knowledge, LLC

• LinkedIn Growth Agency for Entrepreneurs, Executives, Coaches, Consultants, and Agency Owners to join the Top 1% of LinkedIn in their industry so they can close high-ticket deals.
• Digital community of 180,000+ readers promoting self-education through non-fiction books to create more lifelong learners. 
• Developing creative strategies to get books into more hands 
• Consulting with authors on how to turn their book and knowledge into a business.

Founder & CEO

Pavilion

Pavilion is the leading community for networking and learning with other GTM leaders worldwide.

Executive Member

I help Agency Owners, Coaches, and Consultants Join the Top 1% on LinkedIn in 90 Days to Earn High-Ticket Clients | Feat. in Forbes | 500+ clients | 2x D1 Basketball Conference Champion

In March 2020, I left a $22,500/yr job working for UConn Men’s Basketball.

I bet on myself.

On paper, I was on track to build an incredible career with a championship program.

However, my heart wasn’t in it anymore.

6 months prior to leaving, I started a simple Instagram page.

I called it Unleash The Knowledge.

Most people thought I was crazy but I saw the long-term vision.

4 years later, I run a multi-6-figure business from anywhere in the world, all off my laptop.

My Instagram page is now at 127,000 followers, all from starting from 0.

I’ve worked with 500+ authors, coaches, consultants, and founders.

Some of my past well-known clients include: 

- Rick Ross, Grammy-nominated Rapper
- Jim McKelvey. Co-Founder of Square
- Kara Goldin, Founder of HINT Water
- Terry Virts, NASA Astronaut

Today, I help Founders, Consultants, and C-Suite join the top 1% on LinkedIn in 90 days.

If you want to grow your audience on LinkedIn and attract your dream clients using organic social content, here are 3 ways I can help you today:

1. Follow me on LinkedIn, for daily free content

(scroll up and hit the bell to get notified)

2. Get my 30 Free Templates to craft client-attracting content in less than an hour

(go to https://www.authorityauthoraccelerator.com/opt-in-page-6348)

3. DFY LinkedIn Content Writing & Growth - for founders, consultants, and c-suite who want direct support to join the top 1% on LinkedIn and accelerate lead flow to start attracting more clients online.

DM me “DFY” and I’ll get you details.

Thanks for reading this far.

To your success,

Owen “LinkedIn Growth Guy” Sammarone

Owen Sammarone 🚀

I sat on stage in Boston last weekend.

Nearly 200 people staring at me.

I was on a panel with 3 other guys who built massive audiences around non-fiction books.

And something clicked...

Most founders hide behind their content.
They post tips and frameworks but never share the story behind them.
They're terrified to step on a stage and speak their truth.

Here's what I realized: 

Your story is your unfair advantage.

No one else has walked your exact path.
No one else has your failures, breakthroughs, and lessons.
And when you share them, in person, on a stage, in front of real humans, everything changes.

The BookThinkers event in Boston proved this to me.

Here's four lessons I learned from speaking to nearly 200 purpose-driven professionals:

Lesson 1: The energy in the room is different than online.

You can't fake the immediacy of a live audience.
I saw it in their eyes when I shared my journey.

Lesson 2: Speaking on stage forces you to refine your message.

You can't ramble like you do in a post.
You distill fast and learn what actually lands.

Lesson 3: Sharing your journey builds deeper trust than any framework.

People didn't want my 5-step blueprint.
They wanted to connect with someone who's been where they are.

Lesson 4: This ignited a bigger vision for me.

I want to speak on more stages in 2026.
I want to connect deeply and refine my message until it's razor-sharp.

Your audience needs to hear your story, not just your advice.

If you've been thinking about speaking, sharing your journey, or showing up more publicly, do it.

The stage is waiting.

Thank you to Nick Hutchison and the BookThinkers team for putting on a killer event. I can't wait for BookThinkers LIVE 2026.

If you're an author, coach, speaker, or entrepreneur, you will want to be at this event.

Maybe they will let me speak again :)

Brant Menswar Steven Pressfield Kary Oberbrunner Christian F Johnson Evan Carmichael Ryan Lang Zach Hesterberg Elle Petrillo Jill Schulman Maya Payne Smart Cindra Kamphoff, Ph.D., CSP, CMPC Markus Kaulius Ken Rusk Angel Fernandez Jr. Igniting Souls Brand Builders Group Strategic Coach Alex Wieckowski 📚 Matt Karamazov Wayne Mullins Ugly Mug Marketing Chris Green Anjel B Hartwell Anjanette “AJ” Harper Chris Jordan Jonas Koffler Alan Gregerman Fred Joyal

Premium LinkedIn Ghostwriter for C-Suite Leaders | Amplifying ideas, stories, & wisdom that transform industries | 500+ clients served | 2x Founder & Speaker

I flew out of the smallest airport I've ever been to this Thanksgiving.
New Haven, Connecticut.
And I found the best use of a vending machine I've ever seen.

Over the holiday, I traveled through 4 states: New Jersey, New York City, Newport, Rhode Island, and the Connecticut coastline.

Grateful for the journey. 
Grateful for the people. 
Grateful for the experiences.

But what stopped me in my tracks was this:

A vending machine. At the gate. Selling books.

Not chips. Not candy bars. Not overpriced sodas.

Books.

Here's why this matters.

Most vending machines sell you something to pass time.
This one sold you something to spend time well.

Think about it.

You're about to sit on a plane for 2 hours. Maybe more.

You could scroll. You could snack. You could zone out.

Or you could read.

Someone at that tiny airport in New Haven thought about that moment.

They asked: What do people actually need right now?

And instead of defaulting to junk food, they chose knowledge. Story. Connection.

That's thoughtful innovation.

It's not flashy. It's not complicated.
It's just someone paying attention to what serves people better.

I didn't buy a book. I had one with me. Actually, two, but who's counting.

But I stood there for a minute just appreciating it.

Because small decisions like that one add up.

They signal that someone cared enough to reimagine what a vending machine could be.

Not every innovation needs to be a breakthrough.
Sometimes it's just putting the right thing in the right place at the right time.

So here's to the person who decided to put books in that vending machine.

And here's to noticing the small, creative ideas that make life a little better.

What's a small innovation you've seen recently that made you stop and appreciate it?

I was going to write a post about Jensen Huang and how he built NVIDIA around pain tolerance.

But then I saw today’s headline:

“SoftBank sells entire NVIDIA stake for $5.83B to fund AI bets.”

And it hit me…

Jensen and his team are probably completely unfazed.

Because they’ve lived this cycle before.
Booms, busts, hype waves, crashes.
They’ve built muscle memory for volatility.

Jensen once said:
“People with very high expectations have very low resilience… and unfortunately, resilience matters in success.”

That’s why NVIDIA doesn’t flinch when others make short-term plays.
They’ve been thirty days from going out of business before.
Now, they’re the backbone of the AI revolution.

Meanwhile, SoftBank is moving money to further fund OpenAI.

Maybe they’re right. Maybe they’re early.
But there’s a difference between betting on AI and becoming essential to it.

That’s what Jensen mastered:
He didn’t just invest in the wave, he built the board.

And that’s the real lesson for founders and leaders right now:

Don’t get swept up in the next AI headline.
Build something that survives the next one.

LinkedIn isn't a content game.

It's a business game.

Everyone wants deals.
Real revenue.
Real clients.

But here's the problem...

Posting won't get you there.

Thousands of likes = zero dollars.

You need to play offense.
DM people.
Start conversations.

Like you're at a cocktail party.

But most founders kill deals before they start.

Here's what NOT to do:

Mistake 1: You pitch in the first message.

Don't pitch-slap. Full stop.

They don't know you.
Trust is zero.
And you're asking for money?

Don't pitch your offer first
Goal = get a reply, not close
The reply IS the first close
Build conversation, deals follow

I landed a client a $35k deal. Pricing came up in message 7.

Mistake 2: You copy-paste the same template.

No one wants to be prospect #47. I smell templates instantly. So do they. 

Use their name. Their company. Something from their profile. Something they posted. Show you looked. Personalization isn't nice-to-have, it's the price of attention.

Mistake 3: You open with "I help" or "My offer is."

Wrong move.

Compliment their work first
Ask about their business
Share something relatable
Make it their world, not your pitch

Cocktail party rule: don't open with a pitch.

Mistake 4: You DM with a broken profile.

Your profile = your credibility.

They click your name. See "Founder | Speaker | Author." And they're gone. Everyone else is the same. Show how you are different with your bio.

Fix your profile before you send message one. Pro headshot. Clear headline. Consistent posts. They will check. Pass the test.

The truth:

LinkedIn = biggest networking event in your PJs.

Your profile = 24/7 salesperson.

DM like you're building relationships.
Not cold-calling in a boiler room.

Date before you marry.
Trust first.
Business follows.

This door changed everything.

Last week I went back to URI to speak to students.

The night before I went to the basketball game.

And I saw this door again.

Back then it didn't have the branding.
Just a door with a light on.

I was 18.
Scared.
Looking for my shot.

I walked in.
Rang a diner-style bell on the desk.
No one was there.

A woman popped out from around the corner, startled.

I now realize it was her day off.
She was probably just grabbing something quick.
And there I was an 18-year-old kid interrupting her day off.

But I didn't leave.

I asked: "Are there any opportunities in sports where I can get involved?"

That question changed my life.

She gave me a shot. She connected me with the director of basketball ops.
Soon after, I became a student manager for URI men's basketball.

4 years with the Rams.
Then 2 years at UConn as a graduate assistant.

All with Coach Hurley; learning what it takes to be a champion.

He exposed me to self-development.
Books.
Podcasts.
Personal growth.
The idea that you could design your life.

Basketball led to books.
Books led to business.
Business led to me standing in front of students last week, teaching them what I learned.

All because I walked through a door and asked.

Here's what I know:

Life doesn't hand you opportunities.
You create them.

You set a vision.
You take action.
You get in the right rooms.

You open doors.
You ring bells.

Most people wait.
They hope someone will notice them.
They think success happens to them.

It doesn't.

You make it happen.

I was an 18-year-old kid with no connections.
No resume.
No experience.

Just a question.

6 years in basketball.
5 years in business.
A full life of growth, all from one decision.

Don't wait for handouts.
Don't wait for life to happen to you.

Set the vision.
Take the action.

Ring the bell.

Let's address the elephant in the room.

"Why pay $3k for ghostwriting when AI is free?"

I hear this weekly.

Here's what you might be missing:

AI writes content.
It doesn't build trust.
It doesn't convert prospects.
And everyone can tell when you use it.

The founders closing $25k deals on LinkedIn aren't using ChatGPT alone. They're using strategy, voice, and proof that AI can't replicate.

Here's what AI will never do for you:

Mistake 1: AI doesn't know your buyer's journey.

It outputs text.
It doesn't understand your prospect's pain points at each stage.

• Where they are now vs. where they want to be
• The objections that kill deals in your DMs
• The proof points that close high-ticket contracts
• The language your buyers actually use

You need content mapped to buyer intent. AI just guesses.

Mistake 2: AI can't capture your voice or lived experience.

I've seen hundreds of AI posts.
They all sound identical.

• Generic hooks and vague benefits with zero personality
• Your prospects have worked with 10 people who do what you do
• They'll pick the one who feels real and has actual stories
• AI can't share the moment you lost a $30k deal because of positioning
• It can't describe the exact framework you built after 47 client calls
• Even detailed prompts can't fully replicate your voice or substitute a talented writer

Stories convert. Templates don't.

Mistake 3: AI has no strategy behind the output.

It writes what you ask for.
It doesn't plan your next 90 days of content.

• What topics build authority in your niche
• Which formats drive profile views and DMs
• How to position yourself against competitors
• When to educate vs. when to sell

You need a system that compounds. AI gives you one-off posts.

Mistake 4: Let's talk ROI.

You're worried about $3k for ghostwriting.
But you're fine losing one $50k deal because your content sounds like everyone else's.

I've worked with founders who tried AI for 6 months. Zero inbound. 

One consultant hired us and added $70k in revenue in 90 days. 
A leadership coach went from $0 to $52.5k. 
Another client 8x'd his investment and doubled his monthly revenue from $10k to $20k. 

That's the difference between AI content and strategy-backed content. 

AI outputs words. We drive revenue.

If you want content that closes deals, DM me "RESULTS."

18 years old: Lost. Insecure. Graduated high school with a 2.8 GPA and no clue who I was. Got into college, fortunately. 

19 years old: Found identity through basketball. Still unsure of my purpose, but learning discipline, and replicating success.

20 years old: Showing up every day for the basketball team. Wanted to become Mr. Reliable. Busting my butt in the classroom. Joined social fraternity for “balance” 

21 years old: Won a college basketball championship. Felt on top of the world. 

22 years old: Graduated with honors. Two-time basketball champion. Started my own honors society. Got into UConn’s business school and landed the men’s basketball graduate assistant job. 

23 years old: Worked 80+ hour weeks. Earning $22,500/yr. Going to graduate business school 3x a week for 3 hours each day. Started a book Instagram page that would quietly change my life. 

24 years old: Made my first $200 through the book page. Covid hit. Left basketball for good. Moved back home with Mom. Went all in on that book page. Burned the boats on a “safe” career to chase freedom. 

25 years old: Turned that page into a business. Learned how to sell, fail, and rebuild from scratch. Made $100k. 

26 years old: Kept reading. Kept learning. More mistakes and failures but continued to grow. Said yes to a ton of opportunities. Focus was scattered. 

27 years old: Still running book promotion campaigns. Started ghostwriting for business owners on LinkedIn. Started coaching authors and coaches on scaling on Instagram.  Hit my first $30k/month.

28 years old: Still feeling scattered with focus and energy but pressing forward. Scaled to my first $40k/month. Started a podcast on book marketing and recorded 160+ episodes in one year. Leaning further into LinkedIn ghostwriting than book promotions. 

29 years old: Partnering with major CEOs and authors. Building a 7-figure agency and writing the book I wish I had at 18.

Still in the arena. Still learning.

To everyone trying to figure it out, your early chapters don’t define you. 
They prepare you.

Keep building. Keep believing. 
Your future self is already proud of you.

Thank you, Meta for continuing to pay my rent.

Brick by brick.

taplio

The Battle

Neelank Tiwari, MS, PMP

Owen Sammarone 🚀

Followers

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taplio

The Battle

Neelank Tiwari, MS, PMP

Owen Sammarone 🚀

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);}Owen Sammarone 🚀's LinkedIn Performance

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Performance ScoreOwen Sammarone 🚀's LinkedIn Performance