Director Of Compliance

• Sep 2020 - Present

Production Manager

• Apr 2019 - Mar 2020

Production / Manufacturing Supervisor

• Apr 2017 - Apr 2019

Pharmaceutical Manufacturing Production Lead

• Jun 2016 - Dec 2016

Medical Manufacturing Lead

• May 2011 - Mar 2016

•Develop and manage project schedules and ensure all project deliverables including contracts are completed on time. •Conduct weekly meetings with project team to discuss status of project, key deliverables, and assigned tasks. •Conduct design reviews with stakeholders at milestones throughout project lifecycle. •Establish qualification documentation (design specifications, verification/validation test plans and reports, risk management assessments, Process Qualification (PQ), Installation Qualification (IQ), Operation Qualification, and Factory Final Tests) •Design and re-design products for healthcare facilities, assuring product compliance with international, federal, state, and local codes. •Conduct operational, performance, life, environmental, verification and validation tests on components and new products •Write, review, and approve Engineering Change Notices to revise products •Suggest and make improvements to existing and new products. •Travel to customer sites to oversee the installation and function of TAD IV Transfer Devices. •Train clinicians and hospital managers on the best practices of the TAD IV Transfer Device. •Write training and installation procedures for medical device equipment. •Act as Purchasing/Quote Coordinator with all product vendors and suppliers •Utilize NetSuite ERP for inventory management, supply chain and order management. •Interpret BOM’s, SOP’s, and engineered drawings. •Experienced with FDA guidelines and ISO 13485 compliance.