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

• Lead development of innovations with new ETL pipelines and analytic solutions, demonstrating expertise in data engineering and a deep understanding of the data lifecycle
• Guide analytics team in implementing efficient and reliable processes for extracting, loading, and transforming data with Python and low-code software tools for use in reports, dashboards and other end user deliverables 
• Empower business end users to create their own reports from structured SQL views and utilize self-service dashboards to increase audit quality through targeted sampling, entity-based risk assessment, and expedited reporting
• Provide subject matter expertise to cross functional teams improving continuity across IA and other business units
• Manage life cycle of analytics and audit projects using agile methodologies with stakeholders

Project Manager - Data Analytics

• Design, develop, implement, and maintain end to end life cycle of analytic dashboards, data science models, and governance documentation to support audits, investigations, and other projects.
• Collaborate with a large international team to migrate data assets from a warehouse to a cloud data lake environment
• Onboard non technical audience of audit personal to analytics environment through developing and facilitating year long curriculum on data literacy, PowerBI, and other technical concepts
• Empower business end users to create their own reports from structured views and utilize self service dashboards to increase audit quality through targeted sampling, entity based risk assessment, and expedited reporting.
• Gather new AON data assets for Internal Audit and design ETL pipelines to ingest in team data warehouse and data lake navigating GDPR and other data privacy regulations
• Partner with API team from third party workpaper management system to cleanse and ingest department data into data lake and create consolidated SQL views to meet requirements for other analysts.

Senior Data Analyst

KPMG

• Partnered directly with managers and supervisors to complete different aspects of audit
• Focused on Public Sector engagements for single and financial audits of: nonprofits, government, and higher education
• Documented and tested internal controls of clients to ensure compliance with federal requirements
• Utilized data analytics in the audit with IDEA, SQL, and other advanced data wrangling tools to expedite results

Associate Auditor

Illinois State University

• Managed day to day orientation logistics for 4,000 incoming students and 20 student leaders to ensure a comfortable transition to the university
• Utilized SDLC and other development tools to transition orientation procedures to a mobile environment

Orientation Business Office Manager

•Selected by College of Business leadership to analyze recruitment and retention data of first year students in various majors in order to tailor recruitment efforts and identify target schools.
• Independently learned Tableau, R, and STATA to summarize and create visualizations of data
• Worked with econometric professionals to perform predictive analytics and determine factors affecting registration and retention among first year students.
• Expanded research on request of Enrollment Management office to determine probability of student retention to be used by academic advisors

Independent Analyst- Department of Accounting

• Applied Scrum and Agile methodologies to develop a new enterprise risk management program (ERM) for office HR to accurately capture employee time reporting and provide data for resource planning
• Refined office reporting procedures by developing macros, allowing more resources to be invested in visitor experience
• Promoted campus life at Illinois State to potential students during weekly tours, Saturday visits, and open houses
• Trained new staff on office procedures and supervise as they interacted with university visitors

Admissions Ambassador

Responsible for incoming freshmen to the university. Orientation leader for 23 different sessions throughout the summer. Responsibilities include leading discussion amongst student groups, representing the university, and preparing the incoming students for their time at Illinois State.

Preview Guide

Alpha Kappa Psi

May 2016- September 2017- Rush Chair 
• Responsible for developing the recruitment process including: event planning, conducting interviews, and advertising organization
• Utilized social media analytics to determine audience demographics, and created targeted advertisements on Facebook, Instagram, Google, and YouTube to increase brand awareness.
• Increased recruitment attendance by 60%

January 2016 - May 2016- Chapter Treasurer

Active Member

-Complete work papers for single and financial statement  audits for government, non profit, and higher education clients

-Responsible for tasks assigned to a first year associate

-Travel to clients and represent Big Four firm 

-Work directly with supervisors and managers to take audit final

Audit Intern- Public Sector

Miller, Cooper & Co., Ltd.

• Interned in Audit department at a firm focusing in mid-size companies in Chicago area.
• Specialized in financial reporting audits working directly with senior management.
• Gained exposure to accounting in industries such as manufacturing, technology, professional services, and real estate.

Audit Intern

Michael is a data analytics manager within Aon’s global Internal Audit assurance and advisory services team.  

He is a Certified Scrum Master and an experienced data expert focusing on designing advanced analytics and creating automated self-service analytics for audit practitioners. 

In addition to developing data solutions, he is responsible for managing the end-to-end processes of Internal Audit’s Extract-Transform-Load (ETL) process including wrangling and designing new custom views for the audit practitioners.  

Furthermore, he is one of the facilitators of department trainings regarding analytics in audit, often teaching technical skills to a non-technical audience.  

He graduated with a Bachelor of Science in Accounting and Business Information Systems from Illinois State University.

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Neelank Tiwari, MS, PMP

Michael Goodman

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