Quality Assurance/Regulatory Affairs Manager
OCO Biomedical-Albuquerque, NM, 87113
OCO Biomedical has an immediate opening for a quality assurance manager. This position is responsible for all regulatory and quality activities for manufacturer of Class II Sterile Implantable devices. Additional duties are but not limited to: - Developing and maintaining documetation for Master Device Records, Device History Records, Design History files, sterilization validation, compiling, submitting and tracking documentation for 510(k) to FDA. - Liason and contact person with FDA complliance officer. - Develop and implement SOP's and performs internal audits in compliance with FDA regu...