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

Medium

Media Executive of five distinct publications on Medium. 


🐾 Animal Atlas Publication - Animal Atlas Publication
https://medium.com/animal-atlas-publication
  	
Animal Atlas Publication
Animal Atlas Publication is a comprehensive, in-depth exploration of the animal kingdom, much like an atlas would map out regions of our world. It sets the expectation of a wide-ranging overview of various species, habitats, and possibly behaviors.


🔬 AI Ink & BioTechnology - AI Ink & BioTechnology
https://medium.com/ai-ink
  	
AI Ink & BioTechnology

AI Ink & BioTechnology is a forward-thinking Medium publication that explores the latest advancements and discussions in artificial intelligence. Our goal is to bridge the gap between AI and BioTech enthusiasts, researchers, developers, & readers.

💡 Provocative Paradigms - Provocative Paradigms
https://medium.com/provocative-paradigms

Provocative Paradigms
A platform that challenges conventional wisdom & explores alternative perspectives on law and politics. 
Engage with thought-provoking articles that stimulate intellectual discourse, challenge established norms, and inspire critical thinking. 

🖋 Literary Web Publication - Literary Web Publication
https://medium.com/literary-web-publication
 	
Literary Web Publication
Literary Web is for book reviews, literary insights, & storytelling magic. 
We navigate the vast landscape of literature, capturing the essence of every story, review, and literary art form. We aim to create a space where words and ideas are connected.

🌱 Thrive Tribunes - Thrive Tribunes
https://medium.com/thrive-tribunes

Thrive Tribunes

Thrive Tribunes is a vibrant platform sharing triumphs and transformations through effective coaching. This publication serves as a collective voice for success stories from diverse fields such as business, nutrition, life coaching, and beyond.


Thank you 

MarmsRegine

Media Executive

Marmsregine Shop Universal Blog

Intro

In Dream Interpretation & Mind Mapping…

Analysis of dream interpretation through symbolism & subconscious cues to decipher the dream messages. This process helps individuals gain insight into their emotional state & life directions. Mind Mapping Strategies using visual techniques to organize and structure information, aiding in brainstorming, problem-solving, & decision-making. My process begins with a central concept and expands into related subtopics, creating a comprehensive network of ideas. This approach enhances understanding and memory retention.

In Life Coaching…

A former court psychologist from the mid-90s, I have extensive experience in assisting clients with civil cases related to annulments by providing psychological personality profiles. With over 20 years of experience in the psychological realm, I am a mental health advisor and life coach specializing in emotional support and fostering a positive psychology mindset. My approach emphasizes introspection and self-awareness, helping clients achieve clarity on both short-term and long-term goals.

On Academic Coaching…

As an academic coach, I offer tutoring) in allied health sciences, with a particular focus on psychology, nursing, and medicine. In addition to subject matter expertise, I help test strategies & mentor students to study effectively in school.

My target audiences:

    For Personal Development in understanding their subconscious, emotions, life coaching, and mind mapping to gain self-awareness (introspection) & develop personal strategies for growth.

   People Seeking Creativity & Problem-Solving Skills.

    Students and Academic Professionals: People in the fields of psychology, nursing, and medicine.

    Legal Professionals or Individuals in Legal Proceedings needing counseling.

    Individuals Interested in Dream Analysis: People interested in understanding their dreams.

    Educational Institutions or Organizations: To teach study strategies, test preparation, and mind mapping.

Academic Coach for Psychology, Science & Nutrition

Amazon Global Selling

This group is dedicated to the Merch On Demand brand from Amazon. Amazon has approved my first two AI-generated designs from the Barbie-inspired "MarmeeRella Collection," which is now LIVE in several countries, including the USA, UK, Germany, France, Italy, Spain, and Japan. 

If you're registered with Amazon MOD, join our group, and let's transparently grow our businesses together. 

This space allows you to showcase your newest retail designs and newly approved merchandise for global visibility. 

I currently have over 1K merch items on Amazon, available in various languages, primarily English (Amazon.com, Amazon.co.uk); German (Amazon.de); French (Amazon.fr); Italian (Amazon.it); Spanish (Amazon.es); and Japanese (Amazon.co.jp). Here, we can exchange insights on expanding our businesses through consulting and advertising services. 

We aim to collaborate, sharing wisdom on taking our stores global and ensuring profitability as technology and artificial intelligence continue to evolve. 

I invite you to join, sharing both your challenges and victories and allowing others to learn from your unique business strategies. 

Let's capitalize on the emerging trend of AI designs as the public increasingly embraces AI technology and innovation. 

Spread the word and thank you for being a part of this exciting journey! 

Thank you. 


https://www.linkedin.com/groups/14292555/                                                                                             


Welcome to the Amazon MOD Group! 🎉 JOIN us today on LinkedIn.

Amazon Merch On Demand

impact.com

I am sharing my affiliate marketing links to social media for conversion of new and current customers. Learning sales, marketing and advertising is a good skill I’m still learning everyday. Thank you.

Independent Affiliate

https://marmsreginetutors.com/

Marmsregine Tutors, a technology-driven tutoring education company, has primary tutoring services that offer academic tutors (focus - on pre-nursing subjects and other Allied Health Sciences, including English). Our minor services offer foreign language courses Tagalog, English, and English test preparation courses for post-graduate entrance exams. Thank you.

Marmsregine Talent Management

Social Media Link Tree

Varsity Tutors

My first tutoring job was in Highschool Physics and she's an honor student. During that time it was an on-site or in-person tutoring session. By the dawn of the coronavirus pandemic, I accepted online tutoring in the following subjects: Anatomy, Physiology, Pre-Calculus, Biology, Microbiology, Genetics, Pharmacology, and Biochemistry. I was able to navigate among the different colleges on how they presented their online lessons during these distance learning platforms. It is fun to meet students online as we tackle different subjects that they are studying. Thank you.                                                                      http://www.varsitytutors.com/tutors/878759735

Science Tutor

Studypool

I received three badges to tutor in Humanities, Science, and Writing. I want to hone my writing skills for my future goal is to publish a book and be a published writer in any professional journals in science. #MedicalScienceWriter

Academic Tutor - Humanities, Science and Writing tutor 

Buzzsprout

A podcast about the pandemic 2020 on COVID-19 in both layman and technical points of view. We are globally experiencing this pandemic in our current daily lives. What happens to the human intellect and spirit amidst today's health challenges that created a greater impact on our social, psychological, emotional, economic, and spiritual well being should be discussed out in the open among ourselves right here and right now. For any tips, concerns, and questions in our next episode, just email me at richwriter8@gmail.com. Thank you for your time. Be safe.

Creator/Producer/Host

Joule Goddess Lifestyle

I'm excited to help Joule Goddess execute their mission and look forward to contributing as a member of the advisory board. https://app.advisorycloud.com/joule-goddess/boardroom                                                                                                                                 https://app.advisorycloud.com/profile/marmee_regine_cosico

Advisory Board Member

I am a highly experienced and versatile professional with a diverse background in various industries. 

My journey has been marked by a strong focus on empathy and contentment, leading me to excel in roles such as OPI Tagalog Interpreter, Tagalog Legal Interpreter, and Tagalog Language Monitor. 

Additionally, I have experience working as a Regional Trial Court Psychologist and have studied MA in Psychology.

My career goals are centered around utilizing my skills in grant writing, academic coaching, and advocacy. I am also pursuing opportunities in the entertainment industry as a screenwriter and voiceover artist. 

I am interested in roles such as consultant, associate, and member in various organizations. Some potential job titles for me include Grant Writer Intern, Academic Coach for Psychology, Science, and Nutrition, Examiner, Author, Psychologist, Artist, Tutor, Writer, Producer, Interpreter, Advocate, Intern, Host, Consultant, Associate, and Member. 

I possess a strong skill set in areas like bilingualism, healthy living, life skills, fundraising, and empathy. My experience spans industries such as public safety, healthcare, media, and entertainment. With a background in medical studies (MD), pharmacy, and pre-nursing courses, I also have a strong understanding of the medical field and diagnostics. 

My education includes BS/BA degrees in Psychology and Human Biology. I attended MA in Psychology and Doctor of Medicine studies but did not graduate due to financial reasons. I am professionally trained in screenwriting with a Pro-Series 44 certification.

As an academic coach with over two years of experience, I have helped students and professionals excel in psychology, science, and nutrition.

In addition to being an academic coach, I am a certified pharmacy technician, a digital content creator, and a podcaster. 

I have written for various online media platforms, published books on Amazon, launched a Merch On Demand brand, and hosted a podcast on screenwriting. 

I have also obtained certifications in proofreading and poll work and have worked as a court psychologist and a Tagalog legal interpreter. I am passionate about reinventing myself, working hard, and making a positive impact on the world around me. Thank you.

taplio

The Battle

Neelank Tiwari, MS, PMP

MarmsRegine Cosico

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