Kathleen Boland Email and Phone Number

Contract Quality Engineer at Johnson & Johnson Vision Care.

Planet Pharma: Full-time contract with biomedical device company Medtronic (Jacksonville, FL) Associate Product Quality Advocate – June 2017 to Current*Process alleged product complaints of capital equipment and disposable devices in a timely manner per Global Complaint Handling (GCH) procedures.*Communicate with domestic and international customers and partners to gather information and identify reportable events. Perform investigations from product analysis, and determine root cause of product-related events. *Meet key team goals for promoting staging records and closing records. Meet department quality metrics and train on current procedures.*Programs: GCH and SAP

Full-time contract with biomedical device company Zimmer Biomet (Jacksonville, FL)* Completed print updates within project timelines to mark Unique Device Identifier (UDI) on medical device products per FDA requirements and Zimmer Biomet corporate standards. Met project team’s target goal for updating twenty instrument prints per week using Solid Edge. * Created a PowerPoint presentation used by Zimmer Biomet team members for explaining UDI marking requirements and the Pre-Production Run (PPR) process for international vendors. * Assisted Quality team members with obtaining and updating inspection criteria and routing information.* Completed product development requests (FAIs) for Quality and Development teams.* Created validation documents (installation, operational and process qualification) for packaging medical device products with tray and heat sealers.* Performed first article inspections and created documents for engineering change requests, overall change documents, and pre-production runs. * Recorded data to determine 2D Data Matrix requirements for Design of Experiments (DOE) and Gauge Repeatability and Reproducibility (R&R); documented matrix height calculations and assisted Quality team member with selecting representative samples used for testing and operator training. * Supported UDI team member requests: e.g. assembled blocks used for SternaLock Blu fatigue testing.* Trained in Geometric Dimensioning and Tolerancing (GD&T), ethical interactions with health care professionals, clean room gowning procedure, good documentation practices, CMF & Thoracic products, medical terminology, and relevant anatomy training. * Measured with pin gauges, drop indicator, micrometer, calipers, MVP, and optical comparator.

Full-time position at healthcare software & IT (formerly iSirona, LLC)* Implemented Medical Device Data Integration software, DeviceConX (DCX), to connect real-time patient data to Electronic Medical Records (EMRs). Interacted with customers and project team members to support the best connectivity solutions at more than twenty hospital sites; managed between three to eight projects simultaneously.* Compliant to HIPAA, quality system procedures, processes, and security policies.* Configured software for EMRs: Allscripts, Epic, Meditech, and Picis Pyxis.* Created documentation for device connectivity and provided DCX software knowledge to clients and department members. * Documented device connectivity results in Device test plans, architecture diagrams and Go-Live Checklists that were a part of Device History Records (DHRs). * Methodical approach to validation, device, solution testing and troubleshooting issues for clients. * Peer-reviewed and approved DHR documents completed by Integration department members.* Prioritized tasks and managed time and resources towards project goals. * Regular updated customers and project team and department members. * Supported customer requests throughout projects and two weeks after project completion date.* Tested and enabled Java code for calculations, conversions and custom script requests. * Tracked complaints through ticket system in Salesforce. * Traveled to hospitals one to three weeks at a time for medical device software testing with team.

* Learned DSE’s product line of munitions and manufacturing processes.* Measured parts using micrometer and gauges (calipers, drop indicator) and compared them to specifications on drawings using Geometric Dimensioning and Tolerancing (GD&T).on drawings using Geometric Dimensioning and Tolerancing (GD&T).