Artivion, Inc. Kennesaw , GA 30152
Posted 2 months ago
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 has over 1,400 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.
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:
Oversee effective implementation and maintenance of the Quality Management System throughout the company
Support corporate quality objectives and achieve those goals within budget.
Support management as needed with coordination of QSE tasks
Maintain Quality Procedures and ensure contents are appropriate for business; revise as needed
Coordinate corrective and preventive actions, provide solutions, and improvements using root cause analysis tools to resolve issues
Lead and complete CAPA investigations as required
Perform effectiveness verification on CAPA and nonconformances
Monitor nonconformances, CAPAs, GAPs, and QPs to ensure timely completion
Participate in external/internal Quality System audits including managing the backroom.
Effectively drive on time closure of Quality System audit findings
Lead internal audits and support Recovery Partner audits which includes assisting Management with developing the yearly audit schedule
Coordinate and help management develop department training as relates to the area
Provide support to management with training of QSEs
Undertake continuous training and development, including lead auditor training
Backup trainer for QSR on-boarding training to corporate new hires
Manage oversight of the corporate change control process and ensure timely completion
Effectively report data to management on Key Performance Indicators (KPIs)
Contribute to continuous improvement activities including the development of eQMS modules
Execute necessary validations assigned to Quality Systems for the eQMS software
Conduct gap analyses to new or revised Quality System standards and regulations
Assist with the development, maintenance, and support for the eQMS software system
Assist with QMS management review
Key member for any Quality System impacting projects including collaborating with other sites
Complete other functions as they may be assigned
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/systems, or a similar role.
Professional certification: ASQ CQA/CQE/LSS and/or AATB CTBS 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.
This is a hybrid position, based out of our corporate headquarters in Kennesaw, GA. Relocation assistance will not be provided.
Artivion, Inc.