Director - Qual And Reg Mgmt

.**SUMMARY**:Plans, coordinates and directs Quality Assurance programs designed to ensure compliance and continuous production of products consistent with established standards through following responsibilities either personally or through subordinates. Maintain departmental compliance with all regulatory and corporate requirements.**ESSENTIAL DUTIES AND RESPONSIBILITIES**:- May serve as the Site Management Representative and as the Management with Executive Responsibility (MWER).- Ensure quality management system requirements are effectively established and maintained.- Formulate and maintain Quality Assurance objectives and align them with manufacturing and engineering departments.- Establish and maintain programs supporting procedures and quality assurance controls.- Ensures product quality is in accordance with company provisions and standards that regulate activity.- Provide support to solve operational problems.- Conduct risk analysis derived from non-conformity of production process or quality management system.- Conduct quality area metric review and monitor situations, projects, corrections and improvements.- Oversee audits in production areas and quality systems, review situation reports, provide suggestions to perform corrective actions and support actions related to quality assurance functions.- Maintain up-to-date knowledge in the techniques of Quality Assurance/Quality Control, company products and process technologies.- Hire and maintain quality resourcing levels.- Generate development plans for staff.- Promote awareness of regulatory requirements throughout the organization