Barbara Mccarty Email & Phone Number

North Richland Hills, Texas

Currently manage all regulatory, quality assurance and document control personal and systems. Provide leadership for workforce and hold full management representative responsibilities. Oversee all ISO, NIOSH, FDA and company regulatory standards. Manages customer complaints and all corrective action’s. Selected Results:• Introduced process improvements that maximized the Quality System to meet ISO 13485 and FDA 21CFR part 820 standards. • Initiated and launched production of new products that generated new business.• Implemented quality procedures for Respirators and received NIOSH certification.• 510k certification for Respirators• Maintain ISO 13485, FDA 21CFR part 820 and company regulatory standards.• Provide advanced quality planning support in the development and launch of new products and processes.

Garland, Texas

Manager of regulatory, quality assurance and document control. Provide leadership and management representative responsibilities. Oversee all regulatory and company standards.Selected Results:Reestablished quality control system.ISO13485 and AS9100 certification Maintain and manage the company quality program in accordance with customer and company requirements and regulatory agencies including FDA and ISO industry standards pertinent to the success of the company.

North Richland Hills, Texas

Manager of research technicians. Provide leadership on all project coordination for all product introduction, changes, and required maintenance activities. Maintained process SOP’s to ISO and FDA regulations. Selected Results:Introduce new products and raw materials to manufacturing.Interface with operations teams with modification and changes to products and processes.Maintain design/commercialization documentation in Lotus Notes.Provide QA assistance in customer complaintsProvide operations team with engineering change orders.