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. Help senior QSEs manage external audit assessments/internal audit program. Assist 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. To assist with management review, nonconformance oversight, quality planning, and change control.
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.
Qualifications:
- 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.
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.
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Skills Required
- Bachelor's degree in a technical or scientific field or equivalent work experience.
- 1+ years of experience in quality engineering, quality assurance, or similar role.
- Working knowledge of current Good Manufacturing Practices (cGMP), Quality System Regulations, and ISO standards.
- Experience performing root cause analysis and effectiveness verification of CAPAs and nonconformances.
- Experience participating in internal and external quality system audits and audit support.
- Strong analytical and problem-solving skills.
- Excellent verbal and written communication skills.
- Experience with electronic quality management systems (eQMS) and QA software tools.
- ASQ CQA, CQE, or Lean Six Sigma certification.
What We Do
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. Our purpose is to develop simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with diseases of the aorta and deliver breakthrough technologies of unsurpassed quality that have far-reaching impact. Our decades of expertise in treating aortic diseases—coupled with our recent acquisitions and partnerships—have empowered us to offer cardiac and vascular surgeons a suite of aortic-centric solutions such as cryopreserved cardiac and vascular allografts, surgical sealants, prosthetic heart valves, and aortic stents and stent-grafts. Artivion has over 1,250 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.
