Extremity Care - Conshohocken, PA
posted 2 months ago
The Change Manager is a pivotal role within the Extremity Care division, responsible for overseeing the change control program, document control program, record management, and training program to ensure compliance with regulatory requirements. This position requires a comprehensive understanding of FDA regulations and the ability to implement and manage processes that align with these standards. The Change Manager will work closely with various stakeholders to facilitate smooth transitions and ensure that all documentation is accurate, consistent, and compliant with established formatting and template requirements. In this role, the Change Manager will manage the change control program, which includes overseeing the document change order system and workflow. They will provide technical writing support and review for document change orders, ensuring that all changes are well-documented and communicated effectively. The Change Manager will also collaborate with end users to identify solutions that facilitate operational tasks, thereby enhancing efficiency and productivity within the organization. Additionally, the Change Manager will be responsible for revising and finalizing controlled documents, authoring and revising procedures in accordance with FDA, AATB, and other relevant regulations. They will manage the periodic review of controlled documents and coordinate training requirements for new and existing employees. This includes serving as the administrator for the electronic Quality Management System (eQMS), managing record storage and archival processes, and providing quarterly and annual data analytics and reporting for quality events. The Change Manager will also initiate, review, and investigate quality events, determining appropriate containment and preventive/corrective actions. They will support and perform internal and external audits, develop strategies for adopting changes, and ensure that project timelines and objectives are met. A strong working knowledge of regulatory requirements is essential for success in this role, along with the ability to perform other related duties as assigned.