OCO Biomedical has an immediate opening for a quality assurance manager.This position is reponsible for all regulatory and quality activities for manufacturer of Class II Sterile Implantable devices. Duties include but not limited to are: Developing and maintaining documentation for Master Device Records, Device History Records, Design History files, sterilization validation, submit and track all documentation for 510(k) to FDA. Liason and contact person with FDA compliance officer. Develop and implement procedures and processes toward ISO certification Develop and implement SOP's and perform internal audits in compliance with FDA regulations. Initiate any corrective/preventive actions necessary. Manage and report complaints through FDA MDR system. Conduct quarterly Management Review Meetings. Manage all regulatory and quality control activities associated with release and testing of company products. Ensure company readiness for and participation during regulatory inspections (FDA) and audits. Ideal candidate will display a high level of motivation and initiative, adhere to a strong work ethic, be honest, reliable, and punctual. Please email cover letter and resume with references to deanna@ocobiomedical.com Location: Albuquerque Compensation: DOE ranging $45,000.00 to 65,000.00 Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests. newmexico