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ANCA BASINGER, PMP & Risk Management

Plymouth, MN • 612-***-**** • ad40p7@r.postjobfree.com • Linkedin EDUCATION

UNIVERSITY OF MINNESOTA, Minneapolis, MN

Carlson School of Management

Candidate for Master of Business Administration May 2025 Emphasis: Medical MILI, Marketing, Supply Chain Operations and General Management Medical

MILI The Health Care Marketplace

Medical Technology Evaluation and Market Research

MILI Medical Valuation Laboratory

Marketing

MBA Marketing Management & Marketing Analytics

Financial

Financial Accounting &Financial Management

Supply Chain Operations

Sales, Inventory, and Operations Planning

Supply Chain & Operations

Management

Strategic Management Competitiveness

Management of Teams & Leading Others

Competing Globally, Ethical Business

• Member of Medical Industry Leadership Institute (MILI) UMN Alumni

• Member of ASCM & Twin Cities Chapter Member ASCM Association for Supply Chain Management UNIVERSITY OF CRAIOVA, Craiova, Dolj (Romania, European Union) July 1994 Bachelor of Electromechanical Engineering - Major in Industrial Robots

• Electronics Printed Circuit Boards Assembly, Computer Language Programming, Turbo Pascal, AutoCAD

• Member of Association of Industrial and Quality Engineers of Romania – European Union

• Member of ASQ American Society for Quality

PROJECT MANAGEMENT INSTITUTE, Certified Project Manager Professional PMP® # 3006406 May 2021

• Managed People, Processes and Business Environment Managed Projects phases Managed Ten key knowledge areas: Initiation

Planning

Execution

Monitoring and Control

Closing

Project Integration Management

Project Scope Management

Project Time Management

Project Cost Management

Project Quality Management

Project Human Resource Management

Project Risk Management

Project Procurement Management

Project Communications Management

Project Stakeholder Management

Member of Prosci® Change Management Practitioner CCMP ADKAR Certified Member of PMI & PMP-PMI Chapter of MN

Isenberg School of Management UMass Amherst, Certified Lean Six Sigma Management Dec 2021 PG LSS - Lean Management

PG LSS - Minitab®

PG LSS - Certified Lean Six Sigma Green Belt (LSSGB) PG LSS - Certified Lean Six Sigma Black Belt (LSSBB) PG LSS - Lean Six Sigma Capstone

Skills Covered:

Agile & Scrum Management

Digital Transformation

Lean Management: Lean Six Sigma Black Belt

Tools Covered: DMAIC, Jira, Minitab

• IASSC-Lean Six Sigma, Harvard case studies and KPMG capstone projects

• Official membership in the UMass Amherst Alumni Association Certified ISO 13485 Lead Auditor Medical Devices QMS Certified Risk Management for Medical Devices ISO 14971 by BSI Group America EXPERIENCE

ENTEGEE at Medtronic Diabetes, Northridge CA June 2023 – October 2023 Prin PD Project Manager (Contract)

As a Principal PD Project Manager, I successfully orchestrated the development and implementation process for Medtronic Diabetes’ products and services. My responsibilities included: Project Oversight:

• Reviewed project statuses, ensuring alignment with budgets and timelines.

• Monitored projects from initiation through delivery, maintaining a comprehensive view of progress. Page 2 of 5

Risk Management and Issue Resolution:

• Assessed project issues and risks, proactively developing resolutions.

• Ensured quality standards were met, aligning with organizational goals and objectives. Achievement: I spearheaded the successful launch of a global website database for Medtronic Diabetes eManuals, enhancing accessibility and information dissemination. SARACA at Spectralytics, Dassel MN

Project Manager (Contract) April 2022 - June 2022

As a Project Manager, I successfully led a portfolio of 7 projects, overseeing diverse cross-functional teams of up to 15 people. My key accomplishments include:

Risk Management Strategies:

• Addressed, monitored, and implemented risk management strategies for medical device product line transfers.

• Ensured seamless transitions while adhering to stringent quality standards. ISO Class 7 Cleanroom Expertise:

• Proficiently managed medical risk management production transfer validation within an ISO Class 7 Cleanroom environment.

• Maintained rigorous cleanliness standards to safeguard product integrity. Budget and Timing Excellence:

• Achieved all timing and budget goals for projects with budgets of up to $1M.

• Diligently tracked project progress, ensuring efficient resource allocation. Holistic Project Management:

• Orchestrated project phases, considering people, processes, and the business environment.

• Facilitated collaboration across departments, optimizing project outcomes. Achievement: I orchestrated the successful relocation of product line equipment to a new manufacturing location, contributing to operational efficiency and growth. SMITHS MEDICAL Plymouth MN

Quality Specialist (Permanent) December 2017- March 2022 End-of-Life (EOL) Management:

• As a Quality Specialist, I successfully managed the EOL process for over 55,000 SKU products. This involved coordinating phase-outs, use-up strategies, and final obsolescence.

• Notably, I led multiple EOL projects, including the transition from the EU Medical Device Directive (MDD) to the EU Medical Device Regulation (MDR) for both the EU and ROW markets. Obsolescence Management:

• In my role as the Obsolescence Manager, I spearheaded a global cross-functional project team. This team included members from R&D, Marketing, Supply Chain, Regulatory, Sales and Finance. Risk Management for Medical Devices:

• I ensured compliance with ISO 14971, which outlines risk management processes for medical devices. This involved assessing risks according to regulatory and quality standards. Post-Market Experience:

• I identified products with low or no sales over the past 5-7 years, making informed decisions about remediation or end-of-life strategies.

• My liaison work between Marketing, Regulatory, and Supply Chain teams regarding product expiration dates was crucial.

Pre-Market Experience:

• Collaborating with R&D and Quality Teams, I contributed to the successful launch of multiple new products.

• My focus was on aligning data related to parts specifications and Bill of Materials (BOM) products between the ERP Oracle system and PLM Agile and leading the official change approving process.

• My role as an Agile administrator for parts and document control further streamlined operations. Achievements:

• As the Obsolescence Manager, I played a pivotal role in fully obsoleting over 10,000 SKUs.

• Additionally, my expertise as an Agile Administrator and Data Management Analyst facilitated data alignment between ERP and PLM systems.

SMITHS MEDICAL Plymouth MN

Supplier Quality Engineering Specialist (Permanent) September 2016 - December 2017 Page 3 of 5

• I monitored the efficiency of Category I, II, and III suppliers, supporting sourcing and supplier selection.

• Analyzing monthly KPI metrics related to supplier health, quality agreements, lot acceptance rate, and SCAR

(Supplier Corrective Action Requests) was part of my responsibilities.

• My support to Sourcing and Supply Chain included tasks related to supplier qualification, acceptance rate, certification, and audit file completion.

• Notable skills: CAPA (Corrective and Preventive Actions), RCA (Root Cause Analysis), ERP-Oracle, PLM- Agile, ISO 13485, ISO 14971, and FDA 21 CFR 820 cGMP. SMITHS MEDICAL Plymouth MN

Data Management Analyst (Contract) March 2015 to September 2016 Agile IT Project for Global Database Launch:

• As a Data Management Analyst, I led an Agile IT project aimed at launching a new database globally across all Smiths Medical sites.

• This project likely involved collaboration with cross-functional teams, including IT, data management, and stakeholders.

Achievement: Launching Agile PLM Database Globally:

• My successful execution of this project resulted in the deployment of the Agile Product Lifecycle Management (PLM) database worldwide.

• By adopting Agile principles, I facilitated faster delivery, iterative improvements, and close collaboration with stakeholders.

Agile Project Management Principles Applied:

• Agile methodologies emphasize flexibility, iterative development, and continuous feedback.

• Key principles include early and continuous delivery, welcoming changing requirements, and close collaboration between business and development teams. Impact and Value:

• The global database launch likely enhanced data management efficiency, streamlined processes, and improved access to critical information.

• By embracing Agile, I contributed to Smiths Medical’s ability to adapt swiftly to evolving needs. ADECCO at Ecolab, Eagan MN

R&D Engineering Contractor (Contract) December 2013 - December 2014 Project Implementation Leadership:

• As an R&D Engineering Contractor, I successfully led a global project to launch 350+ large equipment assembly products as part of the New Product Introduction (NPI) process.

• My leadership ensured the seamless integration of these products into the market, contributing to the company’s growth and success.

Cross-Functional Collaboration:

• I collaborated effectively with various teams, including Supply Chain, R&D, and Regulatory.

• By fostering cross-functional communication, I achieved alignment and synergy, which is critical for successful project execution.

ERP and PLM Expertise:

• My proficiency in ERP (Enterprise Resource Planning) and PLM (Product Lifecycle Management) systems played a pivotal role.

• Specifically, I ensured that only 30% of new components were introduced, demonstrating a strategic approach to managing existing resources and minimizing disruptions. Skills Showcase:

• DFM (Design for Manufacturing): My understanding of DFM principles likely contributed to efficient product design and manufacturability.

• CAPA (Corrective and Preventive Actions): My ability to address issues proactively and improve processes.

• ISO 9001: My familiarity with this quality management standard underscores my commitment to excellence. Remarkable Achievement:

• The highlight of my tenure was launching 350 new equipment assembly products into the PLM (Product Lifecycle Management) and ERP (Enterprise Resource Planning) databases.

• This achievement not only expanded the company’s product portfolio but also streamlined processes for future management and scalability.

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YAZAKI NORTH AMERICA, Canton MS

PLM Program Management Coordinator (Permanent) December 2011 – July 2013 Project Implementation Leadership:

• As the PLM Program Management Coordinator, I successfully led the project implementation of new electrical wiring harness systems as part of the New Product Introduction (NPI) process.

• This involved launching these systems for 4 Business Units, including contract manufacturing. Key Customer Success:

• My efforts directly impacted key customer Nissan by ensuring that projects, some up to $100M, were launched on time.

• Meeting corporate goals and maintaining a strong relationship with Nissan demonstrates my commitment to excellence.

Timely Coordination and Quality Enhancement:

• I managed multiple automotive projects with precision, ensuring they were delivered on schedule.

• Coordinating teams for product upgrades and rework overnight exemplifies my dedication to functionality and quality improvement.

Technical Proficiency:

• My CAD 3D design skills, particularly using AUTOCAD, contributed to effective project visualization and validation.

• Being an auditor underscores my attention to detail and adherence to standards. Quality and Compliance:

• My familiarity with DFM (Design for Manufacturing), RCA (Root Cause Analysis), CAPA (Corrective and Preventive Actions), and PFMEA / DFMEA (Process Failure Mode and Effects Analysis) ensures robust processes.

• APQP (Advanced Product Quality Planning) and PPAP (Production Part Approval Process) expertise aligns with industry standards.

• Complying with ISO 9001 and IATF TS 16949 demonstrates my commitment to quality management. Remarkable Achievements:

• Launching yearly NPI electrical circuits products for Armada, Titan, and Minivan Nissan’s models expanded the company’s portfolio and market presence.

• Maintaining 100% customer satisfaction and being the #1 Nissan Customer preferred Supplier highlight my exceptional performance.

CELESTICA, Oradea-Bihor Romania, European Union

PLM Project Manager Leader (Permanent) April 2006 - November 2009 New Product Introduction (NPI) Leadership:

• As the PLM Project Manager Leader, I played a pivotal role in launching new product introductions within the printed circuits electronics assembly (PCBA) manufacturing domain.

• My focus on B2B projects ensured that these products met the highest standards of quality and reliability. Cross-Functional Project Leadership:

• I led projects across R&D and Supply Chain, collaborating with internal and external customers such as IBM, Samsung, and Hitachi.

• Coordinating efforts across different departments and stakeholders demonstrates my ability to drive successful outcomes.

Cost Reduction and Efficiency:

• By minimizing material scrap, I achieved Corporate and Customer cost reduction goals.

• My strategic approach not only saved resources but also contributed to the company’s bottom line. Best Practice Recognition:

• My dedication to excellence was recognized when I and my Team I led won the Corporate HQ contest for Best Practice NPI Procedure.

• This procedure became the standard for New Product Introduction across Celestica’s manufacturing sites globally.

Technical Expertise:

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• My skills in DFM (Design for Manufacturing), RCA (Root Cause Analysis), CAPA (Corrective and Preventive Actions), and PFMEA / DFMEA (Process Failure Mode and Effects Analysis) ensured robust processes.

• Complying with ISO 9001 standards underscores my commitment to quality management. Remarkable Achievements:

• Launching yearly NPI PCBA and STB products for Samsung, IBM, Philips, Hitachi, and BSkyB models expanded the company’s portfolio and market reach.

• Maintaining 100% customer satisfaction and being the #1 Samsung and IBM Customer preferred Supplier showcase my exceptional performance.

SUMITOMO ELECTRIC, Deva Hunedoara Romania, European Union NPI Project Coordinator (Permanent) December 2002 - April 2006 Project Coordination and Launching New Products:

• As a Project Coordinator, I successfully prepared, executed, and launched new products (including electrical circuits and airbags) in a contract manufacturing environment.

• My external customers included renowned automotive brands such as Ford, Mazda, Honda, and Land Rover. Part Submission Warrant (PSW) and NPI Product Approval:

• I played a crucial role as the task owner for submitting the final NPI (New Product Introduction) product and the Part Submission Warrant (PSW) PPAP (Production Part Approval Process) testing package to external customers.

• This step was essential for obtaining final approval before mass production, ensuring quality and compliance. Quality Leadership and Certifications:

• As a team leader in Quality Projects, I contributed to manufacturing certifications in ISO 9001 and IATF TS 16949.

• These certifications demonstrate my commitment to maintaining high-quality standards and meeting industry- specific requirements.

Timely Project Delivery and Customer Satisfaction:

• I successfully launched automotive projects on time, showcasing my project management skills.

• My remarkable achievement lies in achieving 100% customer satisfaction. This exceptional track record reflects my dedication to meeting customer needs and expectations. Technical Skills and Achievements:

• My proficiency in CAD 3D AUTOCAD, along with knowledge of quality tools such as CAPA, PFMEA / DFMEA, APQP, PPAP, and PSW, contributed significantly to project success.

• Maintaining the #1 position in Ford and Honda’s Customer Preferred Supplier scorecard is a testament to my excellence.

CERTIFICATES

Certified Lean Six Sigma Management by Isenberg School of Management UMass Amherst Certified ISO 13485 Lead Auditor Medical Devices QMS by Velocity 360 USA Training Certified Risk Management for Medical Devices ISO 14971 by BSI Group America COMPETENCIES

Medical FDA Standards: ISO 13485, ISO 14971, ISO 9001, FDA 21 CFR 820 cGMP Requirements IATF - Automotive Task Force standards TS 16949 APQP, PPAP, DFMEA, PFMEA, MSA, SPC, CAPA ERP systems Analyst: SAP-Matrix JIT MRP, Oracle-Agile PLM, Epics, Epicor MEMBERSHIP

● Member of PMI & PMP-PMI Chapter of MN / PMP Project Management Professional of PMI Institute

● Prosci® Certified Change Management Practitioner CCMP ADKAR

● ASCM & Twin Cities Chapter Member ASCM Association for Supply Chain Management

● ASQ American Society for Quality

● Association of Industrial and Quality Engineers of Romania – European Union

● Official membership in the UMass Amherst Alumni Association

● Medical Industry Leadership Institute (MILI) UMN Alumni member

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