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

Sabahudin Murtic ⚡️

I Help Solopreneurs with AI Content Workflows to Grow their LinkedIn. ⚡️ Get More Done in Less Time with My Newsletter AI Case Study

LinkedIn has 1 billion users. 80% of business happens there.

AI is about to add $15 trillion to the global economy by 2030.

Yet most founders & consultants are doing neither right.

Maybe you are in a similar position:

You have an offer.
You're good at what you do. 
You post on LinkedIn (or not at all)
You gain some attention, but you do not monetize it.

Overall, you're not getting leads or calls.

Here's what's actually happening:

You're creating content, but nobody knows what you're selling
You don't know who your best buyers are or how to find them
Your DMs feel awkward because you don't have a value-based system.

People with great expertise making $10K+/month
While others with the same skills make $50K/month using LinkedIn social selling & value-based outreach campaigns.

Businesses spending 40 hours on tasks AI could do in 4 hours
Money and time just... disappearing

I've been on both sides.

I quit my job 8 months after starting on LinkedIn. 
By year two, I was making consistent, predictable revenue.

I made every mistake. 
Wasted tons of time. 
Eventually, after a lot of testing, I figured out what works.

Now I help other founders skip the trial and error.

➤ Two ways we can work together:

1) Done-For-You LinkedIn Lead Generation (Nomad V Group)
My agency builds your entire LinkedIn system so leads come to you.

Here's what we do:

- Figure out your best offer and who actually wants to buy it
- Find your dream clients on LinkedIn and build a list
- Warm them up with strategic comments before you reach out
- Create value-based resource files
- Create content that builds trust before they book a call with you.
- Send DMs that start conversations and book calls by sharing free value up front.
- Track everything so you know what's working

Result: Qualified calls every month. 

2) AI Strategy & Implementation

- I help you use AI in your actual business operations.
- We look at your current workflows, find where AI fits, and build systems around it.

Result: 
Your team works faster. 
You save 10-20 hours per week. 
Your business runs smoother.

---

LinkedIn and AI aren't going away. 
But every month you wait, the gap gets bigger.

You already know your stuff. 
You just need the right system to turn it into revenue.
If you want help building that system, let's talk.

👉 DM me "INTERESTED" 

---

Want to work together on promoting your tool? 
Email: sabahudin@nomadvgroup.com

Freelance

Sabahudin Murtic

Stop satisfying Claude like a chatbot.

Charlie Hills 🦩 and I put together a full breakdown of how to turn Claude into an operating system for your work.

We demonstrate a real stack:

→ Skills = how work is done
→ Cowork = what data the work is done on
→ Plugins = automation across both

You can check newsletter edition here: https://lnkd.in/dq4t4KxC

If you're still re-explaining yourself to AI every conversation - this will change how you work.


P.S.

What's one task you keep re-explaining to Claude every time?

Unstuck your business with 1h/day of AI social selling | I share weekly content about finding ready buyers, value-first outreach, AI systems, systematic freedom | Co-Founder of Nomad V Group

Claude Skills + Cowork

My honest Jan recap:

Started great. Finished hard.

Win 3 clients
Booked a lot of meetings (but with B2B companies, sales take time).
Lost 1 client.
Got completely stuck with my community launch.

Why? I overengineered the whole thing.

I was building the perfect system before I even knew if people wanted it.

It's like cooking a 5-course meal for guests who never confirmed they're coming.

So I'm postponing the launch.
Not quitting - just changing the approach.

Talk to people first.
Show them what I have.
Invite them when they actually want in.
Then build around real demand.

---

What else went wrong:

→ FOMO about AI was killing me
→ Chasing every new trend, every new tool
→ Jumping from this to that without finishing anything

And then it hit me:

If sales aren't fixed, nothing else matters.

You can have the best AI workflows.
The cleanest systems.
The most beautiful community.

But if you don't have winning sales formula, you're just playing business.

Sell first. Build later.
Sell like crazy, then optimize.

---

What went well:

→ I organized my time better
→ I'm not letting the business depend on me anymore

Because if I'm a slave to my laptop, no amount of money makes it worth it.

My goals are simple:
Travel more. Relaxed evenings. Good dinners. Maybe some music.
Meet great people who are building something from scratch.

Keep it simple. Be grateful for where I am right now.

---

Still not consistent in many ways.
Still need to show up more.
Still need to do more live events (I do zero right now).

But at least I'm honest about it.

What's one thing you're working to improve this month?

The best sales conversations I've had started weeks before the first message.

Not because I'm patient.
Because I stopped treating DMs like a starting point.

Here's what I mean:

Most people connect, immediately pitch, and then get ignored.

The way I approach it is using social selling principles:

- Step 1: Leave relevant comments under their posts

Not "Great post!" garbage.
Real comments that show I actually read what they wrote.
This builds familiarity. They start recognizing my name.

- Step 2: Let trust build naturally

After a few weeks of genuine engagement, something shifts.
They see me as a person, not a seller.
The relationship already exists before I ever enter their inbox.

- Step 3: Move to DMs with value, not a pitch

When I finally message them, it feels natural.
Because it is.

I don't open with "I help founders do X..."
I open with something valuable. A resource. An insight. A genuine question.

The pitch? It comes later. 
Only when the moment is right. 
Only when trust is built. 

The results:

→ More replies (because they already know me)
→ More booked calls (because trust is built)
→ More revenue (because conversations feel natural)

Here's the thing though - doing this without proper system takes forever.

That's why I use Extrovert.

It's not just a commenting tool.

It fetches their recent activity, uses my DM playbook, and suggests personalized openers in my tone of voice.

Human in the loop. AI doing the heavy lifting.

Nothing is automated.
Everything is approved by humans.

Same authentic approach. 10x the speed.

You have 7-days free trial here: https://lnkd.in/gYDJyMty 

( + my small bonus for my audience, because I am their official brand ambassador, I will give you 50% discount for the first month in case you start using this tool - use code: SABA1M )

P.S.

What's your current approach to starting conversations with new connections?

taplio

The Battle

Neelank Tiwari, MS, PMP

Sabahudin Murtic

Followers

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taplio

The Battle

Neelank Tiwari, MS, PMP

Sabahudin Murtic

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);}Sabahudin Murtic's LinkedIn Performance

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Performance ScoreSabahudin Murtic's LinkedIn Performance