Years of experience: 15
United StatesAdvisorExecutive CoachConsulting
Trust Score
Exceptionally trusted; proven professional excellence.
George's Career Path
Jun. 2023 -Present
DemeTECH CorporationDirector of Quality Assurance & Regulatory Affairs
Miami Lakes, Florida, United StatesKey Accomplishments: • Successfully submitted three 510(k) applications and updated all technical files to be compliant with MDR regulations.
• Achieved a successful ISO 13485 MDSAP surveillance audit with no non-conformances.
• Successfully implemented an Engineering Change Control Process to ensure compliance to ISO 13485/MDR & FDA QSRs.
• Developed and implemented a comprehensive quality s...
Feb. 2022 -Jun. 2023
Molecular DesignsDirector Of Quality Assurance
Birmingham, Alabama, United StatesKey Accomplishments:
• Ensured the implementation and maintenance of the quality management system in compliance with ISO 13485:2016 and FDA 21 CFR 820 regulations, including SOP development, master batch record creation, batch record review, deviations, nonconformances, CAPAs, customer complaints, post-market surveillance, and personnel training.
• Acted as the key liaison between the compan...
May. 2020 -Jan. 2022
Wells Pharmacy NetworkDirector Of Operations
Dyersburg, Tennessee, United StatesKey Accomplishments
• Led and Optimized cGMP Manufacturing Operations
• Successfully managed all cGMP manufacturing activities ensuring products were produced on time, within quality standards, and budget constraints.
• Streamlined Pharmacy activities enhancing efficiency and maintaining high compliance with regulatory standards (FDA, DEA).
• Recruited, trained, and developed a highly skilled...