AbbVie acquired Allergan in May of 2020.Continuing as quality lead, supporting projects as they enter design control. Responsibilities include: leading and managing all aspects of the risk management process according to ISO 14971 (including coaching cross-functional team members in a new harmonized process); supporting specification setting, test method development, and DV&V activities; designing in vitro and vivo studies with acceptance criteria to support product claims for regulatory submission.Project lead for risk management and design history file remediation for legacy combination products. Responsibilities include: obtaining cross-functional resources and support, setting project timelines, communicating with leadership, delegating activities, overseeing project status.

Quality lead for multiple novel Class III implantable medical devices requiring FDA Premarket Approval (PMA). Integrated into the team during product concept to incorporate quality early in the design process. Identified need for, and subsequently lead, a quality sub-team comprised of extended team members dedicated to the completion of quality deliverables required for a First In Human (FIH) Early Feasibility Study (EFS) - including quality plans, supplier quality activities, internal quality agreements, clinical supply and manufacturing readiness, incoming inspections, quality control testing and product release. Additionally, pioneered the adoption of a new document management system for New Product Introduction (NPI) pre-design control related deliverables.

Engineering lead for a line extension of the GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement device. Translated customer feedback into user needs. Conducted technical feasibility testing to demonstrate proof of concept and create design inputs. Implemented test method updates based off of the product design, and utilized a risk based sampling approach for testing. Generated Design Verification (DVer) and Design Validation (DVal) plans and coordinated the execution of all activities. Developed risk management deliverables, including design and process Failure Mode and Effects Analysis (dFMEA/pFMEA). Culminating in FDA special 510(k) approval.

Provided process and quality engineering support for 2 families of implantable medical devices. Responsibilities included: NCR/CAPA investigations, root cause analysis, change controls, equipment validations, statistical process control, sampling plan development, risk management updates, complaint support/tracking and trending activities, engineering review, and audit front/back room support.

Internships during the summers of 2014 (Flagstaff, AZ) and 2015 (Elkton, MD).

Co-op with McNeil Consumer Healthcare (division of Johnson & Johnson).