YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Manager Medical Device Quality Systems Management, are to: 

• Be responsible for management of Quality Management System (QMS) processes in accordance with the requirements of ISO-13485 and applicable regulatory requirements;
• Ensure that all changes made to these processes have been evaluated for their impact on the QMS and their impact on the medical devices produced under the QMS;
• Manage a comprehensive, risk-based internal auditing program that is designed to impact the business in a meaningful way in addition to meeting compliance requirements;
• Manage the process to monitor, assess and implement external standards and divisional policies to ensure alignment within the local QMS;
• Provide quality oversight during the implementation and validation of GxP-relevant software and systems;
• Engage with project teams and IT members to ensure that requirements for data integrity are satisfied and that appropriate, risk-based principles for software validation are utilized;
• Be responsible for overseeing a comprehensive, systematic approach to training in order meet ISO, FDA and global regulatory requirements;
• Implement robust strategic training processes and initiatives to meet current and future needs of all Radiology Medical Device employees and promote a continuous improvement focus through training;  
• Be Responsible for managing the external inspection program, including FDA inspections, ex-US governmental agency inspections as well as notified body ISO-13485/MDSAP certification and surveillance audits;
• Serve as a key leader within the Medical Devices Quality Team by providing insight, strategy, resources and energy to aspects of quality that are beyond the core responsibilities of their team.  The role collaborates with all areas of the business to implement and maintain a highly effective quality system and supporting processes;
• Lead a high-performance team that provides broad and deep subject matter expertise in support of the Quality Policy;   
• Continuously adapt with respect to this expertise in order to keep pace with the evolving needs of the business and the customer. 

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

•  Bachelor’s degree Engineering or the life sciences;
• Ten years of experience within a medical device or pharmaceutical    manufacturing environment, preferably Engineering, Quality Assurance and/or Project Management;
• At least three years of functional/team leadership;
• A deep and broad knowledge of FDA 820 Code of Federal Regulations, ISO-13485 and MDSAP;
• Direct experience with implementation and continuous improvement of the quality system;
• History of direct interaction with the FDA and notified bodies during on-site inspections;
• Excellent analytical skills; strong managerial courage; a bias towards making decisions; and a solid understanding of a wide range of quality improvement tools;
• The ability to recognize and manage risk in a methodical manner;
• Strong organization, communication, leadership, and management skills to direct diverse, multi-disciplinary functions;
•  Ability to prepare and manage budgets;
•  Ability to select, develop, and motivate a qualified staff;  
•  High capability adapting to change; dealing with ambiguity; and  seeing situations/challenges from the perspective of other organizations. 

Preferred Qualifications:

• MS in Engineering or the life sciences or an MBA plus a BS in Engineering or the life sciences;
• Direct experience with quality system auditing, preferably as a certified lead auditor.