Manager - Quality Assurance

RRD - Plover, WI is a medical device contract manufacturing facility.  The Quality/Regulatory Manager is responsible for directing, planning, organizing and controlling the processes, procedures, policies and activities for the assurance of the quality of the products according to specifications and in compliance with FDA 21CFR820 & ISO 13485, reporting to Director Quality and Regulatory Affairs. RESPONSIBILITIES: Plan and implement programs that ensure product quality in compliance with QMS standards.Leads the organization is implementation of new products. Implements and drives the culture of continuous improvement.Provide guidance to the site for process validation strategies. Manage the preparation, updating in the system of quality documentation, basing the processes on the standard of ISO 13485:2016, ISO 14971 and FDA 21CFR820.Maintain daily communication with the Departments to follow the established QMS processes.Responsible to follow up and ensure that the personnel of the Department under her responsability  have the proper training to performance the job duties.Oversee the effective use and further impolementation of eQMS systems.Work with customer and suppliers to develop and approve Quality agreements. Ensures adequate operational quality controls are developed to incorpórate customer and regulatory requirements.Ensure best practices are impolemented and industry standards are applied with QMS applications. Implements the risk based approach to the site QMS and operations. Manage site quality plans for large changes and implementations.Ensure manufactured products are appropriately licensed, produced and marked per local state and federal regulations.Builds and devlops a team of quality and regulatory professionals to support world class medical device manufacturing.