DQA Specialist

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 1,400 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.

Responsibilities:

• Complete intermediate reviews of donor records and have the authority to make decisions to pass donors to the next review per relevant standards / SOPs based on review and discretion.
• Provide support to DQA Analysts and Technicians with donor chart and eligibility questions to accurately complete donor chart reviews or process recovery partner charting information.
• Assist management with training functions as deemed necessary to ensure Quality personnel are current to updated standards, procedures, and specifications.
• Ensure donor charts are controlled and meet required quality specifications and regulatory standards prior to release.
• Timely evaluation and disposition of issues concerning nonconforming donors.
• Develop systematic methods for completing work assignments to ensure timelines are met and personal job commitments are accomplished.
• Perform responsibilities of Analyst as needed.
• Understand ISO requirements, AATB, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, product storage and identification, etc.
• Aid management in assuring that specifications, procedures are periodically reviewed for accuracy, validity and functionality, and when necessary, initiate the required changes.
• Provide input to management to facilitate the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job. Initiate change requests and change orders.
• Ability to lead and present ideas that are motivating, by maintaining positive support from associates, by setting a positive example, and by establishing an overall objective and creative atmosphere.
• Effectively complete "other" functions that may be assigned.

Qualifications:

• Bachelor's Degree in the Life Sciences or other scientific field
• Or 3 years experience in tissue industry and/or handling medical records
• 1 year experience as Donor Quality Assurance Analyst required
• Certified Tissue Bank Specialist (CTBS) certification preferred