Carina Riedel

-Professional and disciplinary leadership / Quality Operations Team -Quality Management Representative -Writes functional procedures (SOPs) and work instructions (DPs) -Responsible Coordination of the Quality and Operations related activities as continuous improvement of the Quality System and the internal audit plan -Manages the planning of external body inspections such as Notified Body Organizations -Responsible to manage and monitor the CAPA process

Initiation and management of projects Provide training and guidance to global database users Actively contribute to continual process to meet customer and regulatory expectations Development and implementation of procedures and training materials Support Smiths Medical sites in internal and external audits and inspections relating to product complaints

-Contributes to the process of timely, high quality and consistent product complaints management, including appropriate identification and response to risks, adverse event reporting decisions, collection and documentation of complaints -Set up and manage product complaints in the global complaints database -Communicate with customers, affiliates and internal departments regarding product complaints and document the complaint files