Drew Gardner Email & Phone Number

Jacksonville, Florida, United States

Jacksonville, Florida, United States

Jacksonville, Florida

OwnershipAll Sustaining Activities related to Design Control for Microfix Products Manufactured at three different manufacturing sites.QuickBase Platform utilized for team project management.Ensuring Quality KPI’s remain green by completing sustaining engineering HHE/D’s, IE’s, and CAPA’s.ResponsibilitiesResponsible for training and mentoring new team members Manage sustaining team tasks and objectives in order to drive timely completionManage multiple product lines through various stages of the product lifecycleComplete product updates by updating Drawings, Routers, Bom’s, Labels, etcReview and Approve OCDs for all sustaining product linesFacilitate weekly team meeting with sister manufacturing sitesUtilize problem solving and critical thinking to address any production issuesEvaluate function and risk of product inspected utilizing gages that have been found out of specificationAuthor and execute product testing in order to test design boundaries and determine the design limitsPerform in depth analysis, utilize root cause techniques, and provide/execute a pathway forward for HHE/D's and IE'sAssist in CAPA Review Board by providing design related perspective on process/product for quality related issuesResponsible for advising the complaints team on design related inquiry's Update risk documentation in association with newly discovered risks or increased rate/severity (aFMEA/dFMEA)Complete DHF addendums in order to implement a design change or include new/updated risk documentationReview and Approve completed PMS reportsCreate/Update Work Aids and SOPs associated with Development responsibilities/activitiesMeet with strategic partners in order to gain insight into product performance in the fieldConduct Real Time Aging testing to ensure product/packaging sterility is maintained Assist in surgeon training labs for specific sustaining product lines

Jacksonville, Florida Area

- Re-Design Existing Products to Meet Evolving Customer Needs.- Develop Product Testing Methods.- Create and Execute Product Verification and Validation Testing.- Develop Failure Modes Effects Analysis (FMEA).- Lead and Confer with External Consultants, Contractors and Suppliers in Accomplishing Project Objectives.- Manage the Post Market Surveillance Platform for 24 Different Product Lines.- Understanding of ISO and FDA Quality Systems Regulations and Requirements.- 3D Modeling and Drawing Creation.- Technical Root Cause Analysis.- Manage KPI's associated to product evaluations to ensure all files were completed on time.- Continuous Product Improvement Through Drawing Updates, First Article Analysis, and Change Control

Jacksonville, Florida

Complaint Handling:• Connected with Customer Service across multiple business units to collect and organize complaint information related to Cranial Maxilofacial, Thoracic, and spinal products for complaint entry.• Evaluated complaints to determine reportability of events to National Competent Authorities in accordance with reporting requirements of regulatory bodies in the United States, EEA, Canada, and Asia Pacific.• Coordinated and lead weekly meetings to review adverse event reporting decisions with international subsidiary.• Performed Medical Device Reporting on adverse events per 21 CFR 803.• Analyzed weekly and monthly complaint metrics on open complaints, and closed complaint.Post Market Surveillance:• Maintained and analyzed Customer Feedback reports for surveillance data on product design and function.• Assessed specialty instrument requests for potential complaints.• Developed a new process to monitor the progress of the Post Market Surveillance Reports to ensure timely report completion.• Created and modified Quality System Procedures and Work Instructions.• Authored Health Hazard Evaluations for the determination of Field Actions and / or product recalls.• Completed CAPA activities including corrective action implementation and verification of effectiveness.