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

Craiyon🖍

Craiyon, formerly DALL·E mini, is a research group building generative AI models with focus on text to image.  

Try for free at www.craiyon.com

Co-Founder- all around generalist

humanpredictions

Helped tech companies find the right tech talent. 

humanpredictions is the most comprehensive database of people who code. We leverage public data to help our customers find hidden tech talent outside of LinkedIn.

Leveraging large and niche public datasets, humanpredictions helps our clients find hidden tech talent with general and hard-to-find skillsets outside of LinkedIn, as well as their up-to-date skills, personal email addresses, and other background information.

Beyond being the largest, most robust, and accurate tech talent database, our algorithms predict tech talent events and movements, such as which engineers are most likely to switch jobs in the near future.

Account Executive

Serenity Rose Farm, Cabins & Event Space

Boutique vacation rentals and venues. Oversaw sales, managing clients and construction projects and developed and maintained relationships with employees for start-up retreat center with overnight accommodations and 2 event venues.
-Conducted business development activities including handling leads, customer demos and negotiating contracts
-Managed construction and projects to get six buildings  (2,000-6,000 Sq. ft) functioning for generating revenue
-Created name, logo, branding, website, and online presence including Airbnb, Google, TripAdvisor, Facebook, Instagram, and more with a focus on event and overnight accommodation bookings

Sales & Account Manager

Avenida Brazil Churrascaria Steakhouse

Managed daily operations and consistently executed territory management plan for 3 award-winning restaurant locations leveraging SEO, SEM, sales, and social media driving high volume B2B leads and exceeding monthly sales goals.
-Increased restaurant revenues from $3.5 million to $8 million+ by reimagining events and creating gold standard in customer experience becoming area’s best small group weddings and corporate restaurant destination 
-Introduced private dining and off-site catering program increasing events sales revenues from 3% to 25%+ 
-Built team of 3 sales members and developed sales goals, corporate administrator presentations, and networking strategies using a trusted advisor approach
-Delivered strategic staff training and updated online and in-person marketing materials communicating catering and event benefits to prospective customers
-Met and exceeded monthly quota and commission structures by leading and supporting management on accomplishing key revenue-generating initiatives including marketing, promotions, and contract negotiations 
-Prospected companies, tracked, and maintained consistent follow up nurturing them until appropriate time 
-Managed 1,500+ onsite and off-site events with personal and corporate clients including negotiating, budget proposal, organization, communication, and follow up
-Opened 1 location while rebranding 2 other locations including logos, online presence, website, signage, menus, and printed marketing collateral

Director Sales, Marketing / Operations

HCSS

-Created great experiences for visiting clients by organizing meeting rooms, giving campus tours, and assisting with in-house events for high purchasing clients
-Made outbound communication to customers for software renewals and maintained accurate and timely records in Salesforce

 Customer Success Representative 

City Chick Fashion

Created and developed online lingerie store that obtained eBay top seller status with 100% user satisfaction and stable profit growth
Oversee pricing, market segmentation, and rhetoric of posting for 10,000 items and over $100,000 of merchandise

Sales and Marketing

Austin Technology Council

Conducted market research, collected data, sell memberships & advertising, coordinated promotional activities, liaised with members, delivered presentations, and implemented digital marketing strategies.
-Prospected new members, followed up on sales, negotiated membership rates while developing and maintaining executive level relationships
-Created sales strategies through cold calling, networking,  email marketing campaigns and promotions

Sales and Marketing Associate

Amazon Outreach

Translated discussions between Portuguese and English speakers for 15 hours a day
Travelled into the Amazon rainforest to bring medical support and basic amenities to over 500 families in impoverished communities

Portuguese-English Translator

Solar Meninos do Luz

Coordinated physical education programs with 60 elementary and middle school children in the slums of Rio de Janeiro
Specialized in female motivation and creating progressive, experimental activities with a purpose and life lesson

Education Leader

University of Texas Division of Housing and Food Services

Served as para-advisor to 40 undergraduate female students and addressed academic, mental, and social needs through programming
 Highly trained to respond to emergency situations, customer service, and administrative duties

Resident Assistant

Hiiiiiiiiiiii!! 👋 I'm Melissa! I love getting to know new people and make friends. 

I'm always striving to  improve my personal and professional development in an innovative space. 

Some interesting facts about me! 
-I live in Houston and totally dig it! If you are here, lets meet up for tacos! 🌮
-I love meeting interesting people and making friends!! 
-My dog is a rescue terrier mix named Roux
-My hobbies include watercolor, ceramics, fishing, reading and learning new things
-I'm multi cultural Latinx (Brazilian) & Pacific Islander (Filipino)
-I LOVE food! Trying new and delicious foods is very important to me

taplio

The Battle

Neelank Tiwari, MS, PMP

Melissa Abrantes🖍

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