Quality Systems Engineer III (Hybrid - Austin, TX)

Company Overview

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. For more details, visit our website at www.artivion.com.

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. Lead internal audits and help manage external assessments. Provide training and champion the Quality Management System. To assure the Corrective and Preventive Action Program, and Audit Programs requirements comply with all applicable requirements and to 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:

Essential functions include, but are not limited to:

• Oversee effective implementation and maintenance of the Quality Management System throughout the company
• Support management with coordination of QSE tasks and training
• Coordinate the department training as relates to the QMS department
• Plan and lead internal audits
• Host and participate in external Quality System audits including managing the back room
• Develop corrective and preventive actions, solutions, and improvements using root cause analysis tools to resolve issues
• Perform effectiveness verification on CAPA and nonconformances
• Conduct gap analyses to new or revised Quality System standards and regulations
• Maintain the Quality Manual and Quality Procedures and ensure contents are appropriate for business
• Monitor Quality plans and GAPs for on time reporting of activities and assist where needed
• Effectively report data to management on Key Performance Indicators (KPIs)
• Manage the Standards monitoring program with Regulatory
• Contribute to continuous improvement activities
• Assist with leading the change control process and provide direct oversight
• Contribute on the development of the eQMS software system, including new modules as they are added.
• Help maintain and support the eQMS software systems
• Support Recovery Partner audits including developing the yearly audit schedule
• Assist with QMS management review
• Monitor nonconformances and ensure timely completion

Note: Management retains the discretion to add or change the duties of the job at any time to support current business needs.

Qualifications:

• Bachelor's degree in a technical / scientific related field, or an equivalent field of study, or the equivalent years' work experience.
• 5+ years of experience in quality engineering, quality assurance, or a similar role.
• ASQ CQA/CQE/LSS, AATB CTBS, other professional auditing certification.
• Experience with electronic quality management systems and using 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.

Benefits:

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement

Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.