Quality Systems Engineer I (Hybrid)

Artivion, Inc.•Austin, TX

22h•Hybrid

About The Position

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,400 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. The Position Objective is to be responsible for operating the Quality Management System (QMS), assisting in providing assurance that the Company operates in compliance with all required regulations and standards, helping senior QSEs manage external audit assessments/internal audit program, assisting with assuring 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, and assisting with management review, nonconformance oversight, quality planning, and change control.

Requirements

Bachelor’s degree in a technical / scientific related field, or an equivalent field of study, or the equivalent years’ work experience.
1+ years of experience in quality engineering, quality assurance, or a similar role.
Strong analytical and problem-solving skills.
Excellent verbal and written communication skills.
Working knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.

Nice To Haves

ASQ CQA/CQE/LSS certification preferred.
Experience with electronic quality management systems and using QA software tools is preferred.

Responsibilities

Oversee effective implementation and maintenance of the Quality Management System throughout the company.
Support corporate quality objectives and achieve those goals within budget.
Maintain Quality Procedures and ensure contents are appropriate for business; revise as needed.
Provide support on solutions for corrective and preventive actions and improvements using root cause analysis tools to resolve issues.
Perform effectiveness verification on CAPA and nonconformances.
Monitor nonconformances and CAPAs to ensure timely completion.
Participate in external/internal Quality System audits including supporting the backroom.
Effectively drive on time closure of Quality System audit findings.
Perform the closure review of Internal Audit packets.
Undertake continuous training and development including learning the eQMS.
Provide support and monitor the corporate change control process.
Support running reports and pulling data as needed for Key Performance Indicators (KPIs).
Contribute to continuous improvement activities including improvements to our eQMS.
Monitor the completion of gap analyses to new/revised standards and regulations.
Monitor the completion of Quality Plans for on time activities and closure.
Other responsibilities as assigned.