George Anello - Director of Quality Assurance & Regulatory Affairs, MedDevice Quality Experts

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Work Background

DemeTECH CorporationDirector of Quality Assurance & Regulatory Affairs

Jun. 2023Miami 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 strategy and roadmap that aligned with business objectives and regulatory standards. • Developed and implemented quality goals and objectives, as well as the quality budget. • Collaborated closely with R&D, manufacturing, regulatory affairs, and supply chain teams to ensure seamless integration of quality standards throughout the product lifecycle. • Oversaw the supplier quality and third-party oversight program, conducted audits to identify potential quality issues, and implemented corrective and preventive actions. • Stayed abreast of evolving regulatory requirements and industry trends to proactively identify process improvement and innovation opportunities. • Fostered a quality and continuous improvement culture by organizing training programs, workshops, and knowledge-sharing initiatives. • Led management reviews, served as the management representative, chaired the Quality Board, and held responsibility for market actions. • Managed post-market and complaint vigilance, ensuring timely and effective responses. • Oversaw the quality aspect of design control, ensuring compliance and effectiveness. • Led continuous improvement initiatives, implemented digital quality strategies, and drove the simplification of processes. • Actively promoted a culture of quality throughout the organization. • Managed company-wide training programs to ensure all employees were well-equipped with knowledge and skills.

Molecular DesignsDirector Of Quality Assurance

Feb. 2022 - Jun. 2023Birmingham, 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 company and clients regarding Quality and Regulatory issues. • Developed, trained, and mentored staff to ensure they have the necessary education, training, and experience to perform their job functions. • Provided direction and coordination of all QA and Validation activities, ensuring that other functions impacting product or service quality were aligned. • Supported FDA and other internal/external audits, reporting on the performance of the quality system to senior leadership. • Managed quality control department functions, including receiving inspection, in-process inspection, finished goods inspection, QC Chemistry, and instrumentation triage. • Directed, implemented, and continuously improved quality processes related to manufacturing, returned goods, preventative and corrective actions, non-conforming materials, and inspection control plans. • Achieved financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions.

Wells Pharmacy NetworkDirector Of Operations

May. 2020 - Jan. 2022Dyersburg, 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 team, promoting a culture of continuous improvement and high performance. • Implemented timely corrective actions in compliance with company procedures and regulatory requirements. • Ensured operations conformed to federal, state, and local regulations, including FDA, DEA, 21 CFR Parts 11, 210, 211, and ISO standards. • Led the development and execution of analytical methods, validation protocols, SOPs, and quality documentation, maintaining high standards in manufacturing and quality operations. • Coordinated and directed quality assurance projects to enhance product quality and compliance with industry standards. • Facilitated continuous improvement initiatives through process improvement opportunities, leading to significant operational efficiencies. • Functioned as a leader in promoting professionalism, quality, and safety within the Quality Operations and across the facility. • Provided expert guidance in interpreting regulatory guidelines, ensuring site compliance, and managing changes effectively in a dynamic environment. • Supported Business Units and Research & Development projects by providing critical data, reports, and research insights. • Conducted training sessions for staff on quality assurance practices, enhancing overall operational competence and compliance.

Infinium MedicalDirector Of Quality Assurance and Regulatory Affairs

Jul. 2018 - May. 2020Largo, FloridaKey Accomplishments • Spearheaded all Quality Assurance and Regulatory Affairs functions, elevating department performance through strategic direction and leadership. • Expertly maintained and enhanced the Quality Management System (QMS), ensuring strict compliance with 21 CFR Parts 820 & 210-211, and ISO 13485 standards. • Intensified product quality monitoring, prioritized and addressed complaint trends, and implemented a highly effective and robust Corrective and Preventive Action (CAPA) system. • Played a pivotal role in product lifecycle development, guiding projects from concept to successful commercialization. • Directed comprehensive Quality Assurance audits, ensuring timely facilitation of supplier and internal audits, and diligently following up on CAPAs and observations. • Oversaw supplier management to guarantee the quality of outsourced products, materials, components, and operations. • Selected, developed, and evaluated staff to optimize departmental efficiency, fostering a high-performance culture. • Strategically developed and managed departmental expenses and capital budgets, aligning financial resources with organizational goals. • Actively engaged in management review meetings, providing insightful communication on regulatory and compliance issues. • Supervised the preparation and submission of regulatory documentation, including FDA device listings, establishment registrations, state registrations, and international product dossiers. • Interpreted and applied existing and new regulatory requirements to company products, operations, and procedures, ensuring ongoing compliance. • Represented the Quality Assurance and Regulatory Affairs Departments in internal audits, FDA inspections, and audits by other agencies. • Expertly managed regulatory affairs, quality control, quality assurance, calibration, complaint handling, document control, and employee training programs. • Directed post-market activities to uphold regulatory compliance.

B&M PRECISION, INC.Director Of Quality Assurance, Regulatory Compliance & EHS

Aug. 2014 - Feb. 2018Tampa/St. Petersburg, Florida Area

WincoDirector of Quality & Regulatory Affairs

Jun. 2013 - Aug. 2014Ocala, Florida Area

Emergent BioSolutionsSenior Manager, Quality Assurance

Jul. 2012 - May. 2013Gaithersburg, Maryland

QIAGEN IncQuality Manager

Nov. 2008 - Dec. 2011Gaithersburg, MD