Director Qra Management

Las Visión de Conjunto:**Cordis Corporation** designs, manufactures, and commercializes medical devices used to treat coronary artery disease and peripheral artery disease. Examples of such devices include systems for gaining access to vasculature, angioplasty balloon catheters, stents and stent delivery systems, and access closure devices. As an R&D engineer you will work in the design, development, and testing of Cardiovascular and Vascular Medical Devices. Engineers at Cordis work to solve complex problems to ensure devices meet user needs, and that they are safe and effective for their indicated uses.The**Director QRA Management** will lead a highly capable and dynamic team to drive worldclass continuous improvement designed to deliver outstanding product performance. As the Management Representative, ensure a high level of compliance to internal and external regulations through building cross-functional partnerships and leveraging communication skills throughout all levels of the company. This role is intended to develop into progressively higher leadership levels with increasing spans of control and influence.**Responsabilidades**:- Serve as the Site Management Representative.- 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.- Ensure 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.- Responsible for communicating business related issues or opportunities to next management level- For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures- Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets- Performs other duties assigned as neededCalificaciones:- Bachelor of Science degree or equivalent in a related field- 12 or more years of related experience and/or training; or equivalent combination of education and experience- A Master’s degree in an applicable field of study would be an additional asset- Certifications by an accredited association would be an additional asset**REQUIRED KNOWLEDGE, SKILLS, ABILITIES**- Ability to read, analyze and interpret the most complex documents- Ability to respond effectively to the most sensitive inquiries or complaints- Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors- Ability to define problems, collect data, establish facts, and draw valid conclusions