Caroline Armanious Email & Phone Number

• Manage global project program ($2 B revenue protection) consisting of 6 Design Change Projects with an impact to multiple Suture Product Families manufactured by 5 Ethicon plants located across the globe. • Lead multiple Design Change Projects to implement new Compendial Suture Diameter Test Method • Supported on-site workshops at various manufacturing sites to ensure proper implementation of newly developed Suture Diameter Test Method • Facilitated generation of the technical project Strategies, Protocols and Reports relating to Design Verification of Medical Devices

• Supervised a team of 5 Actalent employees to assure successful project execution • Worked with the customer (Engineering Manager) to establish goals and competencies for each Actalent team member

• Led Change Management Process activities to update Material Acceptance Documentation as part of Life Cycle Management and Center for Raw Materials efforts, generating $650K NC avoidance cost • Successfully presented Material Documentation Changes to the Center for Raw Materials Council in order to obtain consensus of the multi-disciplinary members• Conducted multiple successful Design Reviews with cross-functional teams • Supported Subject Matter Experts from Design Quality, Regulatory Affairs and Clinical to develop Project Strategies

• Reviewed and updated Intra-Aortic Balloon Pumps (IABP) Risk Management Files (DFMEA, Hazard Analysis) • Modified Lifetime Evaluation of Heart and Lung (HL) Machine components specification• Facilitated critical updates to Design Validation Procedure, HL Product Specification and IABP Design Traceability Matrix

• Supported teams in Germany and Sweden on change orders required for launching Heart and Lung (HL) Machines• Assisted Mechanical, Electrical, Software and Systems Engineering Teams with implementing design changes• Generated more than 100 Engineering drawings updates and completed full cycle of the change management process • Facilitated Change Action Board Meetings with multi-disciplinary Stakeholders to obtain consensus on documentation changes

• Managed Corrective and Preventive Actions (CAPA) tracking reports that involved 54 CAPAs• Generated 54 4-Blocker templates for CAPA owners to be presented during CAPA Review Board (CRB) Meetings • Assisted CAPA team in launching Training for engineers in TrackWise system• Ensured compliance of technical records with Good Documentation Practices (GDP)

Fairfield, New Jersey

• Edited 41 documents as part of the European Union Medical Device Regulation (EU MDR) Project• Applied the Code of Federal Regulations: 21 CFR, Part 820 and ISO 13485• Ran various testing on Intra-Aortic Balloon accessories required for Corrective and Preventive Actions (CAPA)• Created 14 Change Notices (CN) for remediation processes• Wrote 36 specifications for spare parts in Quality Management Software (QMS)• Conducted inspection tests using Instron, gages and other instruments

West Caldwell, Nj

• Ensured compliance with banking policies and audit procedures• Maintained and balanced cash drawers on a daily basis• Sold bank products and achieved high sales targets

Cedar Grove, Nj

• Managed drug, medical supplies and maintained patients’ profiles.• Led inventories for outdated, recalled merchandise and stocked medication• Processed medical insurance claims• Complied with company policy regarding lost/broken pills and disposing of them.• Facilitated pharmacy operations through processing sales transactions

West Caldwell, Nj

• Instructed students in English 085, 096 and 096-reading• Coached students in doing online assignments