Joel O'Connor Email & Phone Number

New Brunswick, Nj, Us

• Delivered 10M investment in GenAI to embed intelligence throughout MedTech Quality Systems resulting in over 3M in cost savings annuallyo Due to success of initial investment, 20M investment secured for 2025 to continue GenAI journey• Actively transforming the Labs space by replacing legacy products with single SaaS product across 30+ sites and 5 business units reducing legacy costs by over 2M per year annually• Oversee roadmaps and strategy for portfolio of products that amount to 30M+ annually, driving focus on cost savings, digital transformation and high performing teams• Member of the MedTech Quality Leadership Team acting as conduit between Quality and Technology, providing guidance, insight, negotiation and portfolio management to ensure investments are sound and executed flawlessly

New Brunswick, Nj, Us

• Promoted to Director in November 2019 and currently manage a diverse team of six Product Owners and two Business Analysts who have direct responsibility for a 40M portfolio across three segments• Responsible for defining, revising and shaping 3-5-year vision, strategy, and product roadmaps for all Quality Event Management products within my portfolio across the segments. Leading HPT first launch for Supply Chain.• Took ownership, post go-live, of Enterprise Complaint Management (ECM) and led a turnaround by implementing a stable team concept and a seven-week release cycle that delivered enhancements and value at a blistering pace. This ultimately led to the elimination of over 1M in yearly contractor costs for the business.o Received a Standard of Leadership award for this work• In 2019, delivered a 10M aCAR for a new JJ Vision Complaint Management system which was implemented in December 2020. Reduced two systems and processes for Vision Care and Surgical Vision into one. • Migrated Janssen Complaint team from TrackWise to PQMS in under six months, including data migration of open records into PQMS, saving the business 500K a year in TrackWise charges• Led the CAR generation for the replacement of the Janssen QMS TrackWise platform with a Next Generation QEM ecosystem via a standardized RFI and RFP process. Started in December 2019 with 21 vendors and led the execution of the RFI and RFP processes to a single vendor. $88M CAR package was socialized and approved in Oct 2021 with first deployment planned for Jun 2022.• First Product Line in QCL org to have automated testing deployed across strategic platforms, as well as first Product Line to have all strategic data in CDL.

New Brunswick, Nj, Us

Manage >12M portfolio of software products containing both Quality Event Management (QEM) and Complaint Management (CM) product lines. Software applications include applications developed on-premise using AssurX, Cognizant, EtQ, Remetrex, Siebel, and TrackWise platforms. SaaS platforms include MedVantage running on SalesForce.Oversee >20,000 globally users across all applications and platforms.Manage a team of 5 Product Owners and 3 Business Analysts that support, maintain and manage product lines across all applications.Implement projects of varying sizes from small prototype initiatives <500K to large programs >10M. Develop 2-3 year road maps for all platforms. Provide innovative ideas and solutions back to the business, including use of augmented reality and mobile application support.Maintain regulatory compliance across all product lines.Execute all development initiatives using Agile methodology. Release new, fully validated content every 7 weeks.

Raynham, Ma, Us

Promoted to WW Manager - Quality Management Systems in March of 2017Acted as Product Owner for SCRUM team developing new GxP application on TrackWise platform (React) to manage recalls and field actions worldwide.o Responsible for the following for 2 phases of the project: • Product backlog and product grooming throughout entire project • Managing business team to ensure minimum viable product (MVP) was being delivered • Delivering training plan and fully training all users world wide • Change order creation for existing procedures • System work instruction generation and adoption in QMS • Ensuring scrum team delivered validation documentation to support applicationo Met all deadlines and delivered fully validated GxP software solution • Delivered 1.1M project under budget for 900K • Completed phase 1 in 6 months and phase 2 in 5 months • First Agile GxP project within J&J that was a successo Awarded J&J Leadership award for delivering ground breaking solution in the recall spacePeople Manager for team of two that supports all Quality Systems across DePuy Synthes • Manage day to day support, change requests and rollouts for over 8,000 users and numerous systems, including: Trackwise, EtQ Instinct, ComplianceWire, CATSWeb, and Docusphere.Awarded J&J Leadership Award in 2016 for acting as DePuy Synthes lead for a project to upgrade EtQ Reliance platform from v7 to v11.Held critical role in Synthes acquisition (Johnson & Johnson acquired Synthes in 2012). Executed related activities and milestones for Global Remediation Quality Plan (GRQP), including:• Being the recipient of a J&J Leadership Award in 2014 in recognition of my contributions to GRQP.• Onboarded, trained and supported over 30 sites world wide across legacy Synthes onto the MD EtQ platform.• Supported network infrastructure and Synthes B2B connection into J&J, ensuring performance goals for Quality Systems.• Supported all aspects of the QMS for Synthes

Raynham, Ma, Us

Consulted as a Project Manager, Developer and 3rd level support for the medical device sector of Johnson & Johnson.Biggest accomplishments was to manage a project to develop an application to submit Medical Device Reports to the FDA via electronic submissions (eMDR) for 5 separate Complaint Handling modules. Responsible for project financials, including: project estimates, financial appropriation, budget monitoring, PO creation and financial closure.Drafted all SDLC project documentation including: Capital Appropriation Request, Project Plan, Risk Register, System Design Specifications, and System Requirements Specifications.Drafted and/or up-revved all Computer System Validation (CSV) documentation including: Compliance Analysis, Compliance Report, Traceability Matrix, System Requirements Specification, System Design Specification and all CSV scriptsActed as lead Developer and custom built the eMDR application using the following technologies: XML, HL7 XML, Remetrex, Oracle 10g, EtQ FWE, FTP, LotusScriptDrove the project through the approved change management procedures to implement from Development through to ProductionFinished the project on time and under budget

Johnston, Rhode Island, Us

Acted as a Project Manager for several high profile projects. Also worked as a third tier support in the Windows Client Technologies group for 5000+ users worldwide. Was also responsible for the administration of the Marimba infrastructure while providing .Net development expertise in regards to wrapping packaged software for delivery.♦ As a project manager was responsible for delivering a recommendation and analysis project for Identity and Access Management (IAM). This projects goal was to deliver an enterprise roadmap that outlined how IAM should be implemented at FM Global while analyzing all current processes for improvement. ♦ When working with the Windows Client team responsibilities include 24 x 7 support and management of 6000+ client machines running Windows XP. o Drafted all project documentation, including: project plan, risk assessment, work breakdown structure, network activity diagram, project charter, and change management plan.o Led a multi-department, international project team that included both representatives from IS and from the business. o Produced all deliverables on time and within budget.o Also led a small team to deliver an external password management solution to over 17,000 clients.o Develop custom VBScripts to automate fixes for IE and OS deployments. o Develop custom applications in .Net that support personnel can use to more effectively manage their clients.o Worked as a member of the Vulnerability Watch team that ensured all machines receive patches in a timely basis. Manage the infrastructure used to deliver all patches and develop reports that showcase to management our preparedness for potential viral outbreak.o Work closely with the service desk to lend support whenever needed. This generally includes third level support for OS issues and monitoring of the service desk ITSM system for trouble.

Owned a small business and acted as a Consultant in various roles across IT, Business and Quality for the following companies:American Power ConversionDePuy Synthes, a Johnson & Johnson CompanyEthicon, Inc., a Johnson & Johnson Company EtQ, Inc. Johnson & Johnson Corporate Division Johnson & Johnson Consumer Companies Inc. Lifescan, a Johnson & Johnson CompanyNetwork Computing Services, Inc., a Johnson & Johnson Company Ortho Clinical Diagnostics, Inc., a Johnson & Johnson Company Ortho-McNeil, Inc., a Johnson & Johnson Company Saint-Gobain Technical Fabrics SemiXchange, Inc. Veridex, LLC., a Johnson & Johnson Company

Us

As a Consultant for BELL National, an educational non-profit in Dorchester, MA – May 2006 to March 2007:♦ Initiated, recommended, developed, and managed the move to SQL Server 2005 from Lotus Notes to enhance and improve reporting service and strategy, resulting in access to live data by management for better decision making.♦ Prepared project plan and recommended migration to senior management; orchestrated all aspects of implementation, and utilized Lotus Enterprise Integrator, including its installation and the install of SQL Server 2005 and SQL Server 2005 Reporting Services.♦ Served as Architect and designed the database structure, as well as administered the entire SQL Server environment, creating all tables, views, indexes, database security, stored procedures and backup/disaster recovery jobs. ♦ Used Visual Studio 2005 with Business Intelligence Projects 2005; created over 30 reports using this software and rapidly deployed them to the Report Server.♦ Administered the report server by setting up caches for all of the reports, configuring report properties and parameters, setting up scheduled jobs to publish the reports via email and network shares, and wrote VB.Net code for complex report calculations. ♦ Supplied consulting advice that led to database size reductions of over 50%.♦ As a Domino Administrator was able to configure Domino servers for optimal performance. ♦ Saved thousands of consulting dollars and man-hours for BELL by having an integrated reporting service where none existed.

Worked as a Consultant and completed several major projects using EtQ as a software platform. Played many rolesincluding infrastructure support, user support, developer and at time architect. ♦ Provided services that allowed the company to replace an outdated paper-based quality management system (QMS) with an electronic QMS that met all federal regulations, and successfully passed FDA and ISO audits.♦ Closely collaborated with internal staff through the entire SDLC process, drafting previously non-existent environment and application documentation that supported the quality initiatives and met FDA requirements for software validation (IQ, OQ, PQ, SRD, DDD, Validation Plan, Validation Scripts, Traceability Matrix). Dreamweaver, HTML, Javascript, Oracle, Domino, Cognos Impromptu, SAS, and Sametime.♦ Successfully implemented an Oracle data warehouse for the storage of all quality data allowing for reporting using Cognos Impromptu. ♦ Supported all ETL development and replication activity on a daily basis.♦ Worked closely with several groups at NCS to ensure the stability and reliability of the EtQ infrastructure.♦ Trained closely with EtQ on Reliance infrastructure support and Reliance configuration using both the designer and manual settings customization.

Johnston, Rhode Island, Us

Danielson, Ct, Us

Bachelor Of Arts (B.A.), Psychology

Associate Of Arts (A.A.), Computer And Information Systems