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

Spirhed

Spirhed (formerly the Norwegian branch of CTGlobal) is a leading IT consultancy dedicated to optimizing IT operations and empowering businesses through security and productivity. Since becoming independent in 2021, we have specialized in hybrid IT/OT cloud management, delivering secure, scalable Azure-based solutions that enhance operations and bolster cybersecurity defenses.

At Spirhed, we focus on aligning IT strategies with business goals, ensuring security, operational efficiency, and compliance across sectors like finance, shipping, and government. With a team of Microsoft MVPs, we deliver exceptional expertise through our Spirhed Operations Framework (SOF), covering governance, security, and IT/OT management.

Our mission is to help businesses navigate the complexities of IT by creating innovative, secure, and scalable solutions that drive long-term success. Learn more at www.spirhed.com.

Principal Consultant & Partner

As Chairman of Spirhed, I provide strategic leadership and direction to the company, ensuring that the board effectively sets and achieves key objectives. I collaborate with executive management to drive long-term vision, growth, and sustainability, while maintaining accountability to stakeholders.

Chairman

MODERN MANAGEMENT USER GROUP

Modern Management User Group Norway (MMUGno) is a community for professionals and enthusiasts dedicated to modern IT management solutions. Formerly known as System Center User Group Norway (SCUGno), the group has evolved alongside the shift from traditional on-premises solutions to modern, cloud-based management practices.

MMUGno focuses on sharing knowledge and fostering discussions around Microsoft technologies, such as Intune, Azure AD, Endpoint Manager, and hybrid IT environments. Through workshops, presentations, and networking, the group explores the latest innovations and best practices in IT operations and management.

MMUGno serves as a platform for IT professionals to exchange experiences, stay updated on the latest trends, and improve skills in modern management, security, and cloud-based solutions.

Lead Organizer

twoday Cloud Platforms & Security

Work consist of helping customers drive new technology as efficent as possible with the focus on tech from Microsoft. My expertise lies in Enterprise Mobility Management solutions where medium to large national and international accounts needs help to scale and deliver mobility and security solutions across their organization where they want to adopt Microsoft technology in the most efficent and secure matter. 

As a principal consultant I also am responsible for active customer engagement where I advice on roadmaps and help them scope their vision for the future en regards of Enterprise Mobility and how to manage more advanced and complex workloads and demanding users.

Principal Consultant & Partner 

Work consist of helping customers drive new technology as efficent as possible with the focus on tech from Microsoft. My expertise lies in Enterprise Mobility Management solutions where medium to large national and international accounts needs help to scale and deliver mobility and security solutions across their organization where they want to adopt Microsoft technology in the most efficent and secure matter.

Managing Consultant & Partner

Eniotec AS

Help customers architect and implement custom Microsoft System Management solutions and adopt the latest Windows and Windows Server technology. Work consisting mostly of being on projects at medium to large Norwegian accounts it both Public and Private Sector across all verticals.

Senior Consultant & Partner

Chairman Of The Board

Norsk Data Senter

Responsible for a team consisting of system management consultants where it was my job to make sure that everyone was on the same page in regards of market, technology and customer projects. Coordinating internally and externally resources with PMs.

Team Lead

Help customers implement Microsoft System Management solutions and adopt the latest Windows and Windows Server technology. Work consisting mostly of being on projects at medium to large Norwegian accounts it both Public and Private Sector across all verticals.

Systems Consultant

Partner & Principal Consultant, Spirhed | MVP Enterprise Mobility, Microsoft | Identity & Endpoint - Security & Management - Zero Trust

With over 20 years of experience in the IT sector, I have developed a specialization in identity and endpoint security and management, with a particular focus on infrastructure. As a Principal Consultant, I have demonstrated expertise in both Information Technology (IT) and Operational Technology (OT), giving me a unique ability to understand and solve complex technological challenges.

My key competencies include:

Deep Knowledge of Microsoft Cloud Solutions: I possess extensive experience in assisting clients to integrate and maximize the potential of Microsoft's cloud-based solutions, including Azure, Azure Stack HCI, and Microsoft 365. I am skilled in implementing these technologies in line with the Zero-Trust security model, to balance security, risk, and productivity.

Expertise in Identity and Endpoint Management: I have extensive experience in identity and endpoint management, offering specialized knowledge in analysis, mapping, and development of customized solutions. My expertise also includes securing access and privileged roles, which are crucial in modern IT infrastructures.

Design and Architecture: A significant part of my expertise lies in the design and architecture of IT solutions. I have demonstrated the ability to develop and implement robust, scalable, and secure system architectures. This ability is crucial to ensure that IT infrastructure not only meets current needs but is also prepared for future technological developments and business requirements.

Customized Client Approach: In my role as a key person in the company, I prioritize understanding and adapting to each client's unique environment and business needs. My approach is to tailor technological solutions that reflect the individual DNA of clients, ensuring that these solutions not only meet their current business objectives but are also flexible enough to adapt to future growth and change. This client-focused strategy allows us to offer solutions as unique and varied as the clients themselves.

Role as a Microsoft MVP: My role as a Microsoft MVP attests to my ability to keep pace with rapid technological development and contribute to professional communities through knowledge sharing and innovation. I am passionate about using my extensive experience to drive forward technological solutions that address the challenges of today and tomorrow in IT and OT infrastructure.

I am passionately committed to utilizing my extensive experience and expertise to drive innovation and security solutions that meet the ever-changing needs within IT and OT infrastructure.

taplio

The Battle

Neelank Tiwari, MS, PMP

Marius A. Skovli

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