Prent Corporation is the premier global supplier of innovative, reliable, and sustainable thermoform packaging solutions for the medtech industry. Prent’s global services include in-house package design, tool build, and class 7 and 8 clean room production on Prent-designed and built thermoformers. Locations worldwide include – Wisconsin, Arizona, Texas, Costa Rica, Puerto Rico, Mexico (Baja), Denmark, Malaysia, and China.At Prent I was hired to fill and address a critical short-term leadership role to obtain ISO 13485 and ISO 9001 recertifications for the Janesville, Flagstaff, and Puerto Rico facilities, while also supporting surveillance audits for Baja Mexico and Costa Rica. (As these certifications were set to expire in June of 2024, this was a critical and high-stakes project.) I independently led the 18-day recertification and surveillance audits by effectively preparing the corporation for the audits, managing the onsite audit support activities for Janesville, Flagstaff, and Puerto Rico, while concurrently supporting remotely, the Costa Rica and Mexico audits. To prepare, I travelled to the Prent Malaysia facility and harmonized global best practices. through the alignment of procedures. Following the receipt of the renewed certificates, I concluded the project and successfully fulfilled the tasks contracted in the short-term role.

As a member of the Presource Executive Leadership Team, Guided the Quality Strategy and Operational Quality Management Systems (QMS) for Cardinal Health’s $1+Billion Custom Sterile and Non-Sterile Convenience Kitting Business unit across 6 geographic locations. Waukegan IL, Ft Mill SC, El Paso TX, Glastonbury CT, Indianapolis IN, and Juarez MX. (Internally transferred Indianapolis and Glastonbury Q4 2019. Opened second facility in Juarez Mexico Q1 2021. Closed Ft Mill SC in Q2 2021.)• Retained $70+ Million Department of Defense Contract by resolving contamination complaints and educating the Customer on Sterility Assurance protocols. • Oversaw and executed CAPA Management, Post Market Surveillance, Supplier, Service and Commercial Quality, Distribution, Field Action Decisions, Health Hazard Evaluations, Patient Safety Evaluations, Internal Auditing, Site Quality Plans, Management Reviews, Global Trade, and Metrics. • Reduced customer complaints by 20+% on an annualized basis for the 4-year period.• Facilitated the on-site FDA Inspection of the AeroMed products in Glastonbury, CT in December 2018. Completed Form 483 responses in 3 weeks and successfully closed all inspection actions in 2 months. • Obtained MDSAP certifications for US and Mexico facilities through Audit Readiness campaigns.• Led on-site visits with Chief Medical Officers, Department of Defense officials, Distribution VPs, and Hospital Clinicians to resolve Commercial Quality challenges. • Managed Director of IT Quality Systems, Supplier Quality Manager, Quality Project Managers, Quality Operations Managers, Post Market Vigilance (Complaint) Manager, Clinical Safety Manager, and 280+ indirect Quality Engineers, RN’s, Clinicians, and Technicians.

Drove Remediation and Compliance Master Planning activities that resulted in multiple FDA and BSI MDSAP Inspections concluded with Zero Observations (2016 FDA and BSI Lake Forest and 2017 FDA Costa Rica). • Directed, administered, and coordinated the QMS across all elements of the Lake Forest Site Medical Device R&D Operation. Assessed for compliance Nonconformances, CAPA’s, and Effectiveness Checks. • Developed the Site Quality Plan and Internal Audit Schedule to maintain regulatory certifications.• Conducted regulatory visits resulting in successful audits and maintenance of ISO 13485 Certification.• Functioned as the primary liaison to Regulatory Agency personnel during FDA, BSI, MHRA, or any other 3rd party Competent Authority inspections.

Accountable for the Quality Relationship between Hospira and Q Core Medical Ltd, Israel for the Sapphire Product line of Infusion Pumps, Irrigation Sets, and Product Software. Reported directly to the Corporate Vice President of Device Quality in both corporations and influenced C-Suite Executives.• Directed corporate decisions regarding Quality Service and Repair, Field Actions, Complaints, Regulatory Inspections, Process Improvements, and Product Software Transfers.• Successfully Integrated a shared Post Market Vigilance Database between Hospira and Q Core Medical. • Served as the Single Point of Contact for Quality Assurance between the two companies.

Provided International Competent Authorities written technical responses to resolve Global Medical Device Inquiries regarding complex Service and Repair, Post Market Vigilance, and Product removal inquiries related to customer complaints. Reported directly to the Corporate Vice President of Quality Assurance. • Closed 1500+ Post Market Surveillance, Field Action, and Service / Repair related inquiries. • Reduced by over 80% the quantity of inquiries received from Regulatory Agencies by mentoring international colleagues on the documentation requirements needed to support inquiry closure. In 2013 over 1000+ inquiries were received annually, by 2015 less than 200 inquiries received annually.• Provided training and coaching to significantly improve documentation, objective evidence gathering, remote presentation skills, and technical writing.

Directed daily operations and scheduling for 12 incoming quality assurance technicians by closely communicating with Receiving, Planning, Supplier Quality, and Engineering on Logistics, Supply Chain, and Quality issues.• Mentored IQA personnel on the completion of incoming visual and dimensional testing, commodity change approvals, certificate of comparison activities, and quality information management.• Salvaged over $10MM in inventory through Electrostatic Testing Improvements.• Successfully relocated over 100,000 individual instruments, spare parts, commodities, and unique list numbers from Dallas to Lake County.• Completed 200+ Change Requests and Stakeholder Reviews.

Managed the Biologics manufacturing facilities, quality systems, metrics, equipment qualifications, process validations, and environmental monitoring activities for Monoclonal Antibody Production.• Developed Capital Plan and Budget - Achieved an Annual $6+MM Improvement in Production Yield for Monoclonal Antibodies by updating harvesting techniques with daily media adjustments. • Managed up to 50 Employees. Responsible for interviewing, hiring, training, conflict resolution, scheduling, leaves of absence, Reductions in Force | Termination. • Achieved a 90+% Reduction in Nonconformance through the implementation of effective and sustainable corrective and preventative actions. Mentored staff on Six Sigma and Lean Manufacturing concepts to reduce operational challenges.

• Directly supervised up to 50 manufacturing technicians. Wrote and conducted performance assessments, supported growth planning, and mediated conflicts. • Responsible for the Laboratory Facility, Environmental Monitoring, Cell Banks, Equipment / Calibrations, Media Production, and Service Center Operations. (Including Oxygen, Carbon Dioxide, and Liquid Nitrogen delivery infrastructure.) • Maintained or exceeded planning forecast inventory levels by proactively scheduling production activities. Achieved zero product back orders.

• Independently completed nonconformance, corrective action, investigation, effectiveness checks, and change request documentation.• Reduced overdue CAPA documentation from approximately 200 documents to zero in 10 months. • Supported 3 departments and over 60+ technicians.