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

DataScience Show

As the Founder and Host of DataScience.Show, I am dedicated to creating a platform that empowers the global data science community. DataScience.Show is a livestream series that combines knowledge-sharing with practical insights, connecting professionals, decision-makers, and enthusiasts from around the world. My mission is to democratize data and analytics, delivering engaging, thought-provoking content that bridges the gap between technical expertise and strategic leadership.

Each session is curated to provide value to a diverse audience, from entry-level professionals eager to learn to senior-level experts seeking advanced insights. I collaborate with industry leaders, founders, and innovators to host meaningful conversations on real-world applications, emerging tools, and transformative opportunities in data science.

The heart of my work is building a thriving community. DataScience.Show has grown to reach over 88,000 LinkedIn followers and 53,000 YouTube subscribers, with consistent monthly growth. By leveraging these platforms, I aim to cultivate a space where professionals connect, learn, and grow together.

In addition to hosting and content creation, I foster partnerships with sponsors and collaborators whose goals align with the mission of DataScience.Show. These partnerships provide authentic visibility for sponsors while enhancing the audience experience, creating mutual value. My focus is on delivering measurable outcomes and strengthening connections between sponsors and the data science community.

I am passionate about promoting data literacy, governance, and leadership—key skills for building a data-driven culture. By combining technical insights with an engaging livestream format, DataScience.Show inspires individuals and organizations to embrace data as a transformative tool for success. Through this platform, I aim to educate, connect, and inspire the global data community.

Founder & Host

The Data Analytics Academy

Our magazine is specifically designed to quench professionals' thirst for knowledge in the dynamic world of data and analytics. Our experts write about breakthrough technologies, innovative methods and provide in-depth analysis. 

For our advertisers, we offer customised advertising opportunities tailored to their specific needs. Use our platform to strengthen your brand, expand your network and drive your business.

Founder

Welcome to The Data Governance Digest, your go-to source for mastering data governance, privacy, and compliance. Each episode brings you expert insights, real-world case studies, and the latest trends to help you manage and protect your data effectively.

Whether you're a data pro or navigating new regulations, we’ve got the strategies you need to stay secure and compliant. Subscribe now and stay ahead in the world where data rules and compliance matters!

Podcaster

DatenPioniere

Automation Specialist

Solutions2Share GmbH

AI and Automatisation Specialist

Project Management Group - Germany

Als Vice President Data Science in der Project Management Group - Germany ist es mir eine Freude, Einblicke und Ausblicke in den Bereich Data Science und Projektmanagement zu geben. Unser Verband versteht sich als einziger gemeinnütziger, standard- und methodenunabhängiger Verein zur bundesweiten Förderung und Professionalisierung des Projektmanagements (PM).
Uns ist es wichtig, ein Verständnis für die verschiedenen Projektmanagement-Standards und -Methoden zu schaffen und diese sinnvoll zu verknüpfen.

Als Projektmanager habe ich gesehen, wie die Datenwissenschaft die Art und Weise, wie Projekte durchgeführt werden, verändert hat. Daten sind von unschätzbarem Wert und ihre Erfassung und Analyse kann zur Verbesserung von Prozessen und Leistung genutzt werden. Die gesammelten Daten können nützliche Einblicke in Kundenbedürfnisse und -präferenzen sowie in die Teamdynamik geben und ermöglichen es den Projektmanagern, Entscheidungen auf der Grundlage echter Beweise statt bloßer Vermutungen oder Intuition zu treffen. Mit der ständig wachsenden Zahl verfügbarer technischer Hilfsmittel können Projektprozesse automatisiert und gestrafft werden, um die Effizienz zu maximieren und gleichzeitig sicherzustellen, dass alle Standards mit Ergebnissen von höchster Qualität erfüllt werden. Kurz gesagt: Projektmanagement im Zeitalter der Datenwissenschaft bietet unendlich viele Möglichkeiten für eine höhere Produktivität, ein besseres Kundenerlebnis und letztlich mehr Erfolg.

Vice President Data Science

Deutsche Weiterbildungsgesellschaft mbH

Ich bin der Produktverantwortlicher für die Datenarchitektur bei der DWG und ihren Tochtergesellschaften. Ich kümmere mich um Data Warehousing, Data Governance und Datenkultur. Dazu gehört die Sicherstellung einer konsistenten Datenbereinigung und -verwaltung über alle Systeme hinweg, die Entwicklung einer unternehmensweiten Data-Governance-Strategie und die Förderung einer datenorientierten Kultur innerhalb unserer Organisation.

Ich begeistere mich für Daten - ihre Macht, ihr Potenzial und ihre Möglichkeiten. Ich arbeite gerne mit Teams zusammen, um ihnen zu helfen, den Wert ihrer Daten zu erschließen. Ich bin davon überzeugt, dass die Erschließung des Wertes von Daten der Schlüssel zum Erfolg in der heutigen Geschäftswelt ist, und ich möchte unser Unternehmen dabei unterstützen, dieses Ziel zu erreichen.

Product Owner Data Architecture

Design of DWH based on Azure A central data warehouse based on Microsoft Azure to collect, compile, process and store both structured and unstructured data of customer preferences. It ties in external sources such as Google Analytics, Saleforce Marketing and Salescloud, or Google Ads to ensure reliability when loading data. Validity can be ensured by validating the collected data with metadata management services Implementing tracking solutions Timely, relevant data enables the full lifecycle of analytics for learning interventions. Implementing tracking solutions allows our learners to generate metrics on their intervention progress and us to facilitate the next step in the learner's journey." Our learning analytics platform provides real-time insights into learners' learning processes, which are critical to decision-making to enable them to achieve exceptional performance. That's where timely, relevant data comes in, because it helps organizations get a handle on what's happening." "By using Google Analytics 4 with Firebase as the tracking system, we are able to capture all types of data, including events on websites or apps, analytics by demographic user groups, or funnels based on viewing patterns. Business Intelligence and Report Creation in Power BI Business intelligence and report creation in Power BI help us acquire customers better by gaining insights from customer feedback. Find out the information that work team needs to succeed so that our customers are excited and can improve productivity.

Datendirigent für Data Warehousing & Business Intelligence - Hier spielt die Musik !

Studiengemeinschaft Darmstadt GmbH

For my many roles at SGD, the ability to create custom dashboards is critical to gaining insight into the operations of the business. I have experience using Salesforce, Google Data Studio and Microsoft Excel for this task. Some of the tools I use are : Salesforce Reports and Dashboards, Data Studio, Excel, Tableau, Google Analytics Dashboard for Education. Generally, the dashboards I create are used by management to gain insight into the performance of their departments. For example, one of my major projects was to create a dashboard in Google Data Studio that tracked lead generation numbers in various departments over the course of each quarter. This report was then presented to management and used as an important metric for their performance evaluation. Another project I worked on was creating a custom table visualisation in Power BI that allowed the sales team to track leads generated over time and by campaign channel (e.g. email, call centre, website). This report showed where we were generating our leads, where they were coming from, what regions they were coming from and how many leads were ultimately converted.

Senior Expert Analytics & Customer Insights

Wilhelm Büchner Hochschule

Customer satisfaction is linked to customer loyalty and thus has a direct impact on our attractiveness as an employer. We want to evaluate the user experience in order to improve it at all levels of study (course, faculty, etc.). Student satisfaction is one of the most important factors in attracting new students and retaining old ones. By tracking usage of the various web services, we can ensure that their interests are being met or pointed to relevant topics/courses. Finally, employee satisfaction is a major contributor to organizational culture, which has a major impact on productivity at the individual and organizational levels. 

First, I need to evaluate the various analytics tools available that are best suited for my purposes. Google Analytics is a common starting point, but it is not specifically designed for higher education institutions. Depending on the size/resources of the school, there are other good options - ATInternet, Bitam, and DataSense come to mind. I can't prioritize this step until I talk to stakeholders about their current situation and what they want to accomplish with web/analytics tracking .

I have the ability to track traffic to our website through Google Analytics, but I would need to use a separate tool to track how people are using the website. The most likely candidate for this is Google Tag Manager. To track courses and faculty, I need to set up custom dimensions - unfortunately there is no pre-built solution for either.

DM - Digital Magazin aka. - ECB - Der E-Commerce-Blog

The "digital-magazin" (formerly e-commrce-blog.de) is a medium for people interested in digital topics such as digital transformation, industry 4.0 and digitisation in general. Our readers are also active in or interested in e-commerce and online marketing. The digital-magazin is read by many authorities in these fields.
Contact us: info@digital-magazin.de

Advertising on digital-magazin.de:
- Sponsored Posts
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Sivantos Group

Global Digital Data Analyst 
▪ Set up dashboards for various corporate divisions worldwide 
▪ Developed recommendations for marketing activities in different countries 
▪ Testing and personalization of digital offers 
▪ Developed goals based on KPI's

Digital Data Analyst

AI & Data Marketing Maven: Turning Your Tech into Talk with a Dash of Humor and a Heap of Results – Let's Connect!

I am a digital data analyst with a great background in online marketing, customer service, e-commerce, and strategic process improvement, having helped several e-commerce companies become household names. Over the years, I have evolved from being a high performing individual to a highly experienced digital data analyst who leverages the dynamism of traditional marketing and the far-reaching effect of email & social media marketing in identifying new growth areas, driving sales and brand customer acquisition. More so, I assisted business executives, administrators and investors with lead generation and client acquisition using country-specific marketing strategies, client & market behavior analysis techniques as well as branding concepts that appeal to the human mind.

To say the least, I have shown digital marketing excellence in developing business growth strategies by executing strategic testing and personalization of digital offers that result in customer satisfaction. My focus is geared towards using my refined business management, selling and negotiation talents as well as digital marketing acumen in developing a robust IT teams capable of implementing strategic process improvement measures which reduce operational cost and enhance scalability, documentation & planning, culminating in high return on investments.

Please feel free to reach out if you would like to engage and leverage my expertise in maximizing your business potential. 


taplio

The Battle

Neelank Tiwari, MS, PMP

Mirko Peters

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