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

Andy Mewborn

Distribute.so

I use to be young & cool. Now I do b2b SaaS. 

Husband. Dad. Ironman. Pilot. Taco lover. 

Founder of Distribute // Co-founder of Taplio (acq. by Lemlist) // Early @ Outreach.io.

Creator

A community of over 4,000+ B2B professionals growing together on Linkedin.

• "Brand30 absolutely did wonders for my business." -Maritha Koortzen

• "Brand30 changed the trajectory of my life...To say it’s opening doors for me is an understatement" - Amanda Stern

• "Brand30 provided the group accountability and expert advice I needed to more than double my LinkedIn engagement in just one month" 

🚀 Start Building An Audience Of Potential Buyers On LinkedIn In 30 Days👇

• https://www.brand30.io/

most sales reps kill deals with their follow-ups (here’s how to fix it)

so i’ve been in sales for a while, and the one thing that still blows my mind? how many reps completely tank their chances with shitty follow-ups. not because they’re spamming people, because they’re sending nothing.

"just checking in"
"wanted to circle back"
"following up on my last email"

like, checking in on what? you never gave them anything to actually respond to. prospects aren’t mind readers. if you don’t say something useful, they’re gonna ignore you.

so what actually works? here’s what i’ve seen:

instead of "just following up," try:

"i recorded a 2-min video showing how [similar company] cut their onboarding time by 40%. thought of you because you mentioned this was a bottleneck last time we talked."

instead of "wanted to circle back," try:

"saw this article about [industry trend] and immediately thought of our convo. the part about [specific insight] lines up with what you said about [their challenge]."

instead of "any updates?" try:
"quick question, are you still focused on [goal they mentioned], or have priorities shifted? context changed, so i don’t want to waste your time."

the pattern here is simple:

• give value first
• show you actually listened
• make it about them, not your quota
• make it easy to respond (ask a specific question)

i built a tool that does this automatically. it pulls call recordings, videos, and docs into one link so you’re not just sending another empty "checking in" email. not because reps are lazy, because prospects are busy, and they don’t have time to guess what you want.

Andrew Mewborn

Sellers

Should you ever badmouth competitors during sales calls?

A) Always - Highlighting their flaws strengthens our value proposition
B) Strategically - Only when directly asked about specific weaknesses
C) Rarely - Focus on our strengths without comparative negativity
D) Never - Unprofessional and damages industry relationships

P.S. - 15,000 sellers stopped writing follow-ups. Take the 2-min quiz to see what they switched to: https://lnkd.in/eNYQ3DeQ

Should you ever badmouth competitors during sales calls?

Sellers

What's more valuable: relationship selling or solution selling?

A) Relationships first – People buy from people they trust
B) Solutions first – Buyers want problems solved, not friends
C) Value selling – ROI conversations close deals faster
D) Consultative approach – Be an advisor, not a vendor

P.S. - Still writing follow-ups manually? This 60-second quiz builds you an AI system that does it for you: https://lnkd.in/eNYQ3DeQ

What's more valuable: relationship selling or solution selling?

Sellers

What’s the worst sales advice you’ve received?

A) “Always be closing” – Aggressive pressure turns prospects off
B) “Fake it till you make it” – Authenticity matters more than acting
C) “Price isn’t a problem” – Dismissing budget concerns backfires
D) “Never take no for an answer” – Respect boundaries to build rapport

P.S. - Still writing follow-ups manually? This 60-second quiz builds you an AI system that does it for you: https://lnkd.in/eNYQ3DeQ

What’s the worst sales advice you’ve received?

Sellers

Should you ask about budget in the first call?

A) Always - It qualifies prospects immediately and saves time
B) Sometimes - Only after establishing clear interest and need
C) Rarely - Money talk too early creates resistance
D) Never - Discussing budget before value cheapens your solution

P.S. - If your follow-ups take longer than 60 seconds, you're doing it wrong. Take the quiz: https://lnkd.in/eNYQ3DeQ

Should you ask about budget in the first call?

Sellers

Commission vs. salary: What motivates salespeople best?

A) Pure commission – High risk, high reward drives peak performance
B) Base + commission – Security with upside creates optimal motivation
C) Straight salary – Removes pressure, focuses on customer success
D) Team bonuses – Shared success eliminates internal competition

P.S. - Steal my 1-pager email follow-ups: https://lnkd.in/eQr9JQhq

Commission vs. salary: What motivates salespeople best?

Sellers

Should sales managers still carry a quota?

A) Full quota – Can't coach what you don't practice 
B) Half quota – Need skin in the game 
C) Token quota – Just enough to stay sharp 
D) Zero quota – Let leaders lead, sellers sell

P.S. - Took me 2 min to find out I was wasting 11 hrs/week on follow-ups. Take the quiz, get your number: https://lnkd.in/eNYQ3DeQ

Should sales managers still carry a quota?

Sellers

How much does luck contribute to success in sales?

A) Significantly – Being at the right place at the right time often makes all the difference.
B) Moderately – Luck plays a role, but skill and effort are more important.
C) Minimally – Success is mostly the result of hard work, strategy, and persistence.
D) Not at all – It's all about skills, planning, and execution. Luck doesn't come into it.

P.S. - Still writing follow-ups manually? This 60-second quiz builds you an AI system that does it for you: https://lnkd.in/eNYQ3DeQ

How much does luck contribute to success in sales?

Sellers

Do good looks matter in sales?

A) 100 % – Beauty opens doors before product does
B) A bit – Looks earn attention, skill seals the deal
C) Barely – Confidence > cheekbones
D) Zero – Quota is blind to pretty faces

P.S. - Still writing follow-ups manually? This 60-second quiz builds you an AI system that does it for you: https://lnkd.in/eNYQ3DeQ

Sellers

Is AI replacing salespeople or empowering them?

A) Replacing – Only top 20% of reps will survive automation
B) Empowering – AI handles admin, humans handle relationships
C) Overhyped – Human psychology can't be automated
D) Transforming – The role evolves but never disappears

P.S. - 15,000 sellers stopped writing follow-ups. Take the 2-min quiz to see what they switched to: https://lnkd.in/eNYQ3DeQ

Is AI replacing salespeople or empowering them?

Sellers

Remote selling vs. in-person: Which closes more deals?

A) Remote wins – Efficiency and scale beat face-to-face
B) In-person dominates – Trust requires physical presence
C) Hybrid approach – Use both strategically based on deal size
D) Industry dependent – Complex B2B needs in-person relationships

P.S. - If your follow-ups take longer than 60 seconds, you're doing it wrong. Take the quiz: https://lnkd.in/eNYQ3DeQ

Remote selling vs. in-person: Which closes more deals?

Sellers

Which comp structure would you rather live on?

A) 70 % base / 30 % commission – stability rules
B) 50 / 50 – balanced risk-reward
C) 30 / 70 – big swings, big wins
D) 0 / 100 – eat what you kill, baby

P.S. - Steal my 1-pager email follow-ups: https://lnkd.in/eQr9JQhq

Which comp structure would you rather live on?

Sellers 

How far would you go to close a high-value deal?

A) Bend policies – Adjust terms slightly to meet client demands
B) Offer extras – Throw in freebies or extended support
C) Escalate internally – Loop in execs to approve exceptions
D) Never compromise – Stick to standard offerings to maintain integrity

P.S. - Took me 2 min to find out I was wasting 11 hrs/week on follow-ups. Take the quiz, get your number: https://lnkd.in/eNYQ3DeQ

How far would you go to close a high-value deal?

Sellers

Do sales reps really need to use the CRM?

A) Every detail – Data is the new oil 
B) Key stuff only – Quality over quantity 
C) Bare minimum – Just enough to not get fired 
D) CRMs kill deals – I track my pipeline in my head

P.S. - 15,000 sellers stopped writing follow-ups. Take the 2-min quiz to see what they switched to: https://lnkd.in/eNYQ3DeQ

Do sales reps really need to use the CRM?

Sellers

Who's harder to sell to?

A) CFOs – Every penny is their first-born child 
B) CTOs – They'd rather build than buy 
C) CEOs – Good luck getting past their gatekeepers
D) Procurement – Where deals go to die slowly

P.S. - Took me 2 min to find out I was wasting 11 hrs/week on follow-ups. Take the quiz, get your number: https://lnkd.in/eNYQ3DeQ

Sellers

Worst thing a manager can say?

A) "Just trust the process"
B) "What's your plan to hit quota?"
C) "Let me join your next call"
D) "Top reps aren't struggling"

P.S. - If your follow-ups take longer than 60 seconds, you're doing it wrong. Take the quiz: https://lnkd.in/eNYQ3DeQ

Sellers

Which role do you think is the hardest in sales?

A) SDR 
B) Account Executive 
C) Account Manager 
D) Sales Manager 

P.S. - Steal my 1-pager email follow-ups: https://lnkd.in/eQr9JQhq

Which role do you think is the hardest in sales?

Sellers

What's the biggest lie in B2B sales?

A) "I'll circle back next quarter" (They won't) 
B) "Budget isn't an issue" (It always is) 
C) "We're the decision maker" (Committee of 12 enters chat) 
D) "Your product is perfect" (Here comes the ghosting)

P.S. - Steal my 1-pager email follow-ups: https://lnkd.in/eQr9JQhq

Sellers

Is "fake it till you make it" acceptable in enterprise sales?

A) Essential – Confidence sells more than competence 
B) Sometimes – Strategic bluffing is part of the game 
C) Risky – One Google search can tank your credibility
D) Never – Authenticity beats artifice every time

P.S. - Took me 2 min to find out I was wasting 11 hrs/week on follow-ups. Take the quiz, get your number: https://lnkd.in/eNYQ3DeQ

Is "fake it till you make it" acceptable in enterprise sales?

Sellers

How do you respond when a prospect ghosts you late in the deal?

A) Persistence: Keep following up until you get a response, showing your commitment to helping them.
B) Pause and Reflect: Give them space for a while, then reach out with a new angle or valuable insight.
C) Closure Attempt: Send a "break-up" email to prompt a final decision, making it clear you're moving on.
D) Seek Feedback: Reach out for feedback to understand what went wrong and learn for the future.

P.S. - If your follow-ups take longer than 60 seconds, you're doing it wrong. Take the quiz: https://lnkd.in/eNYQ3DeQ

How do you respond when a prospect ghosts you late in the deal?

taplio

The Battle

Neelank Tiwari, MS, PMP

Andy Mewborn

Followers

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taplio

The Battle

Neelank Tiwari, MS, PMP

Andy Mewborn

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);}Andy Mewborn's LinkedIn Performance

Ready to grow your LinkedIn presence?

Performance ScoreAndy Mewborn's LinkedIn Performance