Director Device Quality

AstraZeneca

Gaithersburg, Maryland

AstraZeneca is seeking a Director of Device Quality to join their team in Gaithersburg, MD. This role is responsible for leading and managing the Device Quality team, ensuring compliance with relevant regulations and standards for medical devices. The Director will oversee the development and implementation of quality systems, manage audits, and drive continuous improvement initiatives. Key Responsibilities: * Lead, mentor, and develop a high-performing Device Quality team. * Ensure compliance with FDA regulations (21 CFR Part 820), ISO 13485, and other relevant global quality standards. * Oversee the design, development, and execution of the Device Quality Management System. * Manage and conduct internal and external audits. * Collaborate with R&D, manufacturing, and other departments to ensure quality is integrated throughout the product lifecycle. * Drive continuous improvement in quality processes and systems. * Investigate and resolve quality issues and deviations. * Prepare and present quality metrics and reports to senior management. Qualifications: * Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. * Minimum of 7-10 years of experi

Ref. TYQVK

Info
-- / --
Info

Arrastra un PDF aquí, pega una URL o toca para seleccionar un archivo