Director, Post Market

Job description

Director, Post Market Department: Quality: Employment Type: Full Time: Location: Gainesville, FL: Reporting To: Chief QARACA Officer: Description: The Director Post Market Quality Assurance provides leadership and direction in ensuring the sustainability of an effective and compliant Quality Management System (QMS) Post Market QA program, that includes the following key processes: - Post Market Surveillance - Product Correction and Removal Program (Field Safety Notices, Recalls, etc) - Complaint Management - Vigilance Reporting - MDR reporting - Recall reporting - EUDAMED reporting Key Responsibilities: - The Director of Post Market Quality Assurance is responsible to develop, lead, and direct a Quality Assurance team that manages the key post market QMS Processes indicated in the purpose section above. - Responsible for identifying and resourcing improvement programs to ensure suitability and compliance to all applicable Medical Device regulatory regulations and standards. - Oversees the timely collection, analysis, and reporting of all post market quality signals to determine the need for escalation, correction and removal, or corrective/preventive actions. - Responsible for mana...