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

Endologix, Inc.

Primary responsibility for Procurement, Planning, Distribution, and Logistics.  
Continually perform in-depth analysis of situations and data, in consideration of a variety of factors.
Responsible for Supplier Management and identification of suppliers (primary & secondary) and strategic partners to meet the sourcing needs of the company.  
Partner with Supplier Quality in the evaluation of both new and existing suppliers.  Establish and maintain positive relationships with suppliers, while actively pursuing service, financial, and quality improvements. 
Responsible for planning and creation of schedules materials and resources to ensure business needs are satisfied.  
Continually interface with Production, Quality Assurance, and Finance in review of material inventory status, prioritizing purchase orders and implementing action plans as necessary.  
Responsible to manage issues related to design changes and material shortages to avoid or minimize organizational impact.

Senior Buyer/Planner

American Cleanstat, LLC

Responsible for inventory Management to include: movement, accuracy, distribution of ACS product, customer and financial performance implications.  
Manage and control SOP’s with regards to inventory and quality control and was instrumental with obtaining ISO certification. 
Created new Work Instructions for key functional areas that affect Inventory accuracy.
I take pride in a continuous alignment and collaboration with ACS Management teams to train them with the most current processes and procedures. 
Developed and maintain Inventory Reports capturing slow, excess and obsolete inventory. 
Updated ERP systems to bring to most recent technologies in order to work more effectively and efficiently. 
Implemented Lot Control 
Implement new reports creating better efficiency for rebate programs
Implemented reason codes for more efficient inventory Control and reporting
Implemented product expiration date reporting for better inventory Control 
Responsible for coordinating annual physical inventory at each distribution location. 
Implemented sales comparison up down reports to highlight opportunities for the sales group
Responsible for Sales tracing reports. I take pride in spearheading continues process improvement

Inventory Control Manager

Johnson & Johnson

Was responsible for the coordination of the Mentor consigned inventory program, with a focus on providing oversight management, escalation of consignment team issues as well as the creation of ongoing process improvement. Responsible for audit control for over 4,000 audits per year. Creation of automated reports that helped to streamline work, created better transparency, efficiency  and productivity for the team.  Collaborated with all levels of the business to optimize inventory management.

R&D Project Coordinator
Managed the R&D department’s multiple project schedules; Created a web tool while working as the project lead, to assist internal and external customers, saving the company approximately $100,000 annually; Facilitate cross-functional team meetings to ensure alignment; Coordinate with task owners using networking and collaboration skills to ensure on-time outcomes; Liaison between internal departments and approved vendors to ensure timely parts ordering and delivery; Provide support to the sales field, ; Super user creating purchase orders in the Ariba purchasing system; Coordinate and collaborate with Demand Planners and Procurement to ensure adequate inventory levels are kept on HLD consumables
Selected as the SME and Trainer for the Endoscope qualification process

EVOTECH Connector Project Manager / Training Lead (Kelly Services) 2008-2010
SAP rollout; Implemented processes to ensure the success of future training and security access for SAP users; Instrumental in the creation of an online training site that provided users links to training materials and classes, Communicated and tracked company’s franchise impact alalysis accross all departments; Created and revised business processes to bridge gaps that existed in providing accurate qualified endoscope information; Responsible for the development and management of department’s automated tools to ensure accurate information for field sales and external customers

Inventory Management Specialist, R&D Project Coordinator, Marketing Project Manager, Training lead

Lead and point person for California inventory issues and DMV audits.
Managed DMV quarterly inventory audits for 700 car dealerships and registration services.
Responsible for working with the Sales team and Auditing Sales Contracts/DMV paperwork
Managed Inventory in Oracle
Wrote knowledge-base articles to train new employees and empower untrained employees to assist customers.
Selected to write E-learning programs insuring consistent training for auditing California DMV records.
Chosen to train rotating temporary staff due to proven expertise.

Auditor

Experienced business professional with a demonstrated history of working in the Medical Device Industry. Skilled in Inventory Management, Purchasing, Planning, Analytics Project Portfolio Management, Business Process Improvement, Training, and Competitive Analysis.

taplio

The Battle

Neelank Tiwari, MS, PMP

Wanda Sinclair

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