Quality Systems Engineer II

Quality Management System OperatorCompany Overview: Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America.Position Objective: Responsible for operating the Quality Management System (QMS). To assist in providing assurance the Company operates in compliance with all required regulations and standards as determined by both internal and external assessments. Support internal audits and help manage external assessments. Provide training where necessary. Assure the Corrective and Preventive Action Program (CAPA) and Audit Program requirements comply with all applicable requirements and keep management advised of the status of these programs. To assist with management review, nonconformance oversight, quality planning, and change control. To administer the electronic quality management system and perform gap analysis as identified.Responsibilities:Oversee effective implementation and maintenance of the Quality Management System throughout the companySupport corporate quality objectives and achieve those goals within budgetCoordinate corrective and preventive actions, provide solutions, and improvements using root cause analysis tools to resolve issuesPerform effectiveness verification on CAPA and nonconformancesConduct gap analyses to new or revised Quality System standards and regulationsMaintain Quality System Procedures and ensure contents are appropriate for businessParticipate in external/internal Quality System audits including supporting the backroomEffectively report data to management on Key Performance Indicators (KPIs)Contribute to continuous improvement activitiesUndertake continuous training and development, including lead auditor trainingMonitor nonconformances and CAPAs to ensure timely completionEfficiently drive on time closure of Quality System audit findingsPerform root cause analysis and investigation support to resolve problemsManage oversight of the corporate change control processProvide management with training support of QSE IAssist with the development, maintenance, and support for the eQMS software systemsSupport Tissue Recovery Partner audit assessmentsAssist with QMS management reviewMonitor Quality plans and GAPs for on time reporting of activities and assist where neededQualifications:Bachelor's degree in a technical / scientific related field, or an equivalent field of study, or the equivalent years' work experience3+ years of experience in quality engineering, quality assurance, or a similar roleASQ CQA/CQE/LSS and/or AATB CTBS or other auditing certification preferredExperience with electronic quality management systems and using QA software toolsStrong analytical and problem-solving skillsExcellent verbal and written communication skills, including business writingWorking knowledge of current Good Manufacturing Practices, Good Tissue Practices, Tissue Banking Regulations, Quality System Regulations, and ISO Standards