Quality Systems Engineer II

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 products include aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. With over 1,600 employees worldwide, the company has manufacturing facilities in Atlanta, Georgia; Austin, Texas; and Hechingen, Germany, and sales representation in over 100 countries.

About the Role

Responsible for operating the Quality Management System (QMS) to ensure the company complies with all required regulations and standards through internal and external assessments. This role supports internal audits, manages external assessments, provides necessary training, and ensures the Corrective and Preventive Action Program (CAPA) and Audit Program meet applicable requirements while keeping management informed of their status.

Responsibilities

• Oversee effective implementation and maintenance of the Quality Management System throughout the company.
• Support corporate quality objectives and achieve those goals within budget.
• Coordinate corrective and preventive actions, provide solutions, and drive improvements using root cause analysis tools to resolve issues.
• Perform effectiveness verification on CAPA and nonconformances.
• Conduct gap analyses for new or revised Quality System standards and regulations.
• Maintain Quality System Procedures and ensure contents are appropriate for business.
• Participate in external/internal Quality System audits, including supporting the backroom.
• Effectively report data to management on Key Performance Indicators (KPIs).
• Contribute to continuous improvement activities.
• Undertake continuous training and development, including lead auditor training.
• Monitor nonconformances and CAPAs to ensure timely completion.
• Efficiently drive on-time closure of Quality System audit findings.
• Perform root cause analysis and investigation support to resolve problems.
• Manage oversight of the corporate change control process.
• Provide management with training support of QSE I.
• Assist with the development, maintenance, and support for the eQMS software systems.
• Support Tissue Recovery Partner audit assessments.
• Assist with QMS management review.
• Monitor Quality plans and GAPs for on-time reporting of activities and assist where needed.

Requirements

• Bachelor’s degree in a technical/scientific field or equivalent work experience.
• 3+ years of experience in quality engineering, quality assurance, or a similar role.
• ASQ CQA/CQE/LSS and/or AATB CTBS or other auditing certification preferred.
• Experience with electronic quality management systems and QA software tools.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills, including business writing.
• Working knowledge of current Good Manufacturing Practices, Good Tissue Practices, Tissue Banking Regulations, Quality System Regulations, and ISO Standards.