Quality Systems Engineer II

Artivion; Kennesaw (GA); On-site; USD 80,000 - 110,000; Full time

Job summary

Artivion, Inc., headquartered near Atlanta, seeks a Quality Management professional to oversee the QMS, support audits and CAPA, and drive continuous improvement across the organization.

The role administers the eQMS, coordinates corrective actions, and ensures compliance with GMP, Good Tissue Practices, Tissue Banking Regulations, QSR, and ISO standards. 3+ years in quality roles and relevant certifications are preferred.

Qualifications

• Bachelor's degree in a technical/scientific field or equivalent experience.
• 3+ years 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, including business writing.
• Working knowledge of GMP, Good Tissue Practices, Tissue Banking Regulations, QSR and ISO Standards.

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 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 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

Skills

Analytical thinking

Problem solving

Verbal and written communication

Quality assurance mindset

Education

Bachelor's degree in a technical / scientific field

Tools

Electronic QMS (eQMS)

QA software tools

Job description

Company Overview:

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 four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 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. For additional information about Artivion, visit our website, 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. Support internal audits and help manage external assessments. Provide training where necessary. Assure 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. To administer the electronic quality management system and perform gap analysis as identified.

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 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 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

Qualifications:

• Bachelor's degree in a technical / scientific related field, or an equivalent field of study, or the equivalent years' 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 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.

Equal Opportunity Employer

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.