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About the Role

Responsible for operating the Quality Management System (QMS) to ensure compliance with regulations and standards. Assists in managing external and internal audits, CAPA, and other quality processes.

Responsibilities

• Oversee effective implementation and maintenance of the Quality Management System.
• Support corporate quality objectives and achieve goals within budget.
• Maintain Quality Procedures and revise as needed.
• Provide support on solutions for corrective and preventive actions and improvements using root cause analysis.
• 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 for Key Performance Indicators (KPIs).
• Contribute to continuous improvement activities, including improvements to the 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.

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

Skills

• Quality Management System (QMS)
• Root cause analysis
• Corrective and Preventive Action (CAPA)
• Electronic Quality Management Systems (eQMS)
• Quality System audits
• Change control
• Key Performance Indicators (KPIs)
• Gap analysis
• Quality Plans
• Good Manufacturing Practices (GMP)
• Quality System Regulations
• ISO Standards

Location

• Atlanta, Georgia

Work Type

• Full-time

Experience Level

• 1+ years

Education Level

• Bachelor's degree

Benefits

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

About the Company

• 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.
• Visit our website at www.artivion.com.

Equal Opportunity

• 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.