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

Senior Quality Systems Program Manager

Support various Operation Units (OUs) within the Neuroscience portfolio by leading Field Corrective Actions, support FCA audits, and other post-market surveillance activities via coordination with various stakeholders globally. Portfolios of the OUs include:
•	Neuroscience
•	Medical Surgical
•	Cardiovascular

Among other responsibilities, identify and develop process improvements to increase effectiveness, efficiency, and compliance. Project(s) include:

• Enterprise Customer Quality Recall QMS Transformation Project
- Support as the FCA planning team lead, the Enterprise Customer Quality (CQ), a corporate initiative to create a simplified and streamlined QMS Governance and shared processes across the company to support the new Operating Model (re-org), while maintaining compliance, reducing the burden, and improving effectiveness and speed.

• Enterprise Customer Quality Recalls Electronic Storage Repository Project
- To create a standard single shared electronic FCA document repository for storing all FCA files.
- Create a Shared - Enterprise FCA electronic repository and folder structure for all FCA files across portfolios. 
- Discontinuation and Migration of hard-copy FCA files (FCA Books).

Quality Systems/Compliance Program Manager - Neuroscience, CV, and Medical Surgical Portfolios

•	Primary Global PHO/FCA coordinator/contact (SME)
•	Collaborate globally and cross-functionally to execute on product hold orders, which may involve the following functions: Customer Service, Post Market Quality, Distribution Centers, Manufacturing Facilities
•	Develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. 
•	Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. 
•	Serve as a liaison between the company and the various governmental agencies. 
•       Work directly with operating entities to ensure that inspections, statistical process control analyses, and audits are conducted continuingly as specified to enforce requirements and meet specifications.

Quality Systems Specialist - Post Market Risk Management

Medtronic Brain and Spine Therapies

• Primary Global PHO/FCA coordinator/contact (SME)
• Collaborate globally and cross-functionally to execute on product hold orders, which may involve the following functions: Customer Service, Post Market Quality, Distribution Centers, Manufacturing Facilities
• Serve as a liaison between the company and the various governmental agencies.

Associate Quality Systems Specialist - Post Market Risk Management

Medtronic Spine & Biologics

•	Processed all order types: stocking orders, sets, consignments, loaners, credits, and drop-shipments from the Memphis facility. Issued appropriate debit/credit for product movement between OUS markets. 
•	Processed all documentation that was pertinent to Letters of Credit, Temporary Imports, and Carnets.  Understood harmonize tariffs and how to determine the tariff by utilizing the Schedule B Commodity Reference Manual. 
•	Worked closely with the Regulatory department to coordinate documentation and maintain compliance. 
•	Promoted Touchless Order Production through Electronic Channels, such as MSTAR, GHX, and EDI.

Principle Customer Care Rep. - Service Innovation Group (SIG)/Automation Advocate (SME) 

•	Trained/developed team members to operate independently to accomplish team goals
•	Oversaw daily production to ensure work is processed within established timeframes; coordinated with other Leads to align DC staff.
•	Functioned as primary subject matter expert (SME) for receiving processes.

Distribution Group Lead IV, Memphis Order Processing

Domestic Order Processor II

I am a Quality Systems and Compliance Subject Matter Expert with a passion for enhancing and advocating quality best practices and strategic marketing. I have over 10 years of experience in the Medical Device and Technology industry, where I have honed my skills in distribution and manufacturing procedures, customer service, quality systems, and compliance. Additionally, I have a strong background in strategic marketing, specifically in crafting and executing marketing plans for both large-scale corporations and non-profit organizations.

In my free time, I love volunteering with children, engaging in marketing projects, spending quality time with family, and exploring new places through travel.

taplio

The Battle

Neelank Tiwari, MS, PMP

Brittany Washington, MBA

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