Ashley Sinclair Email & Phone Number

Cincinnati, Ohio, United States

Responsible for the day-to-day management of the Quality Management Systems (QMS) for numerous clients. Responsible for client management and ensuring Quality Management Systems maintain regulatory compliance to US and EU regulations. Managed and assisted in the development and maintenance of quality management systems and ensure compliance to the following list of regulations: US 21 CFR (Code of Federal Regulations) part 820 (Quality System Regulation), Regulation (EU) 2017/745 (European Regulations on Medical Devices) & Regulation (EU) 2017/746 (European Regulations on In Vitro Diagnostic Devices); ISO 13485:2106 (Medical Devices – Quality System Management), and ISO 14971 (Medical Devices – Applications of Risk Management to Medical Devices). Managed and implemented the install of customized electronic quality management systems on electronic document management systems such as MasterControl.

· Proved to be a resourceful asset to the management team by providing original solutions, new concepts, actively negotiating and resolving differences, and employing constructive criticism.· Increased bar revenue through marketing featured cocktails from limited resources.· Responsible for ordering, maintaining inventory and stocking bar items.· Orchestrated social functions (private parties, business meetings, formal engagements, etc.)

Certificate, Social And Human Service Assistant

Bachelor'S Degree, Business Administration And Management, General

B.S., Business Administration, Focus: Healthcare Administration