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

Google

•	Improved the closure of vulnerabilities out of SLO by 43% and improved unresolved vulnerabilities over a year by 94%.  
•	Created dashboards using SQL to monitor and track the progress of open, closed, and fixed bug. 
•	Maintained internal communications with briefing reports and status update of the improvement of resolve vulnerabilities. 
•	Created runbooks outline routine operations tasks within Vulnerability Management. 
•	Provided guidance and support to engineers on security fixes with high priory vulnerabilities that needs to be released into production.  
•	Responsibility for managing the end-to-end vulnerability management workflow and provide technical support to system and technology owners to propose mitigation and remediation solution.  
•	Understanding of how to classify and prioritize the risk of new vulnerabilities based on the operating environment.

Program Manager, Privacy, Devices & Services · Engineering - DSPA Security

Premium Pieces

Co-Owner/Fashion Designer

Motorola Solutions

•	Managed Coverage Testing projects totaling $1.5 million, with a goal to achieve 97% reliability in service areas.   
•	Maintained customer and internal communications with briefing reports and status updates to ensure trust with the stakeholders. 
•	Optimized large scale equipment orders for strategic ordering and equipment backlog alignment to meet the project needs.  
•	Steered multi-faceted Engineering resources of 8 to optimize deliveries within project lifecycle of Coverage Testing. 
•	Created Statement-of-Work (SoW) documents for sub-contractor purchase orders.
•	Coordinated multiple teams to execute defined field implementation and acceptance efforts.
•	Collected, analyzed, and interpreted data to assist a large project team.
•	Provided guidance and support cross functionally while acting as the direct contact on all matters impacting implementation of the program or the success of the project.

Senior Project Manager

Boeing

•	Lead process improvement efforts to improve production rate by 36% for the 737 program which made the company over $1,000,000 in sales a month and reduced operating cost by $10,000 in wing production. 
•	Manage equipment used in maintenance training for equipment service personnel and engineers on the operation and maintenance of automated tools and equipment that support production. 
•	Present weekly reports to management outlining project deliverables, critical factors, and any variances to project.
•	Lead supplier engagements to analyze technical proposals, negotiate bids, and monitor performance through project completion.
•	Collect and analyze machine data using SQL for process improvement, root cause analysis, and preventative maintenance.
•	Diagnose and correct equipment for system malfunctions to decrease down time and develop new maintenance plan.
•	Modify, test, calibrate, and document system configuration to meet compliance requirements.
•	Collaborate with cross-functional teams to implement innovative solutions for defective equipment and improve production flow.

737/777x Equipment Engineering Program Manager

•	Manage software data that allows technicians to pre-load line replacement units prior to installing them on a plane.
•	Provide documentation of software and how to upload/download it to the system for the FAA.
•	Install, troubleshoot, and fix hardware/software issues that the customers may have.
•	Re-imaging (using clonezilla and Fast Image) to desktops and laptops, while applying security patches for customer use.

Equipment Engineering IT 

Boeing Research & Technology

Design a system that incorporate an Endoscope with an Ultrasonic Transducer. The endoscope will always the user to inspect the confined space without the user being in the space. The Ultrasonic Transducer will allow the user to inspect the structural integrity of the rivet without having to take off the sealant.

Software & Hardware Engineer

Cameron attended Purdue University, where he received a B.S. in Electrical and Computer Engineering Technology with a concentration in Digital Systems and a minor in Technology Leadership Innovation. Cameron is currently a Program Manager at Google. In this role, he supports Nest, Wearables, Fitbit, North, Stadia and Fi by making sure that any exploitation is triage and remediated. 
 
Prior to this, Cameron served as an electrical engineer with The Boeing Company.  He has experience in wing production on the 737 NG, P-8, the Max, and 777X programs. After leaving The Boeing Company, he transitioned into Engineering Project Manager at Motorola Solutions where he helped put coverage in the state of Washington and Butte, Montana. His experience includes embedded systems, programming, project management, hardware and software design and developing new systems.

Cameron is a part of the Institute of Electrical and Electronics Engineer and National Society of Black Engineers. For many years, he has held positions in the chapter and regional levels and still has an active role within NSBE today. He is also a mentor for the 100 Black Men of America, where he mentors high school kids and helps foster an interest in STEM related fields. In his free time, Cameron likes giving back to the community as a strong STEM advocate and engaging in continued educational opportunities. Through his past employments, he has acquired the skills of responsibility, integrity, and positive work ethic. Cameron is a dedicated team orientated person that seeks to provide opportunities that promote networking, professional development, and cultural awareness for all.

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The Battle

Neelank Tiwari, MS, PMP

Cameron W. Burford

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