Establishes, directs and ensures that all document control, training, compliance, CAPA and management reporting activities are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations that apply to the products manufactured by Bard Medical. Subject matter expert for MasterControl, Change Control, Training, Internal Audits, Notified Body assessments, FDA audits, and quality systems compliance.
Ability to travel as required for the position and lift up to 25 pounds
This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratory environment and manufacturing environments with associated conditions.