DQA Analyst

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. The company’s 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 and manufacturing facilities in Atlanta, Georgia; Austin, Texas; and Hechingen, Germany.

About the role

Ensure that all donors accepted and processed at Artivion are properly identified, controlled, and meet all required quality specifications and regulatory standards prior to release for distribution. May function as a primary Region Contact, facilitating all donor charts within the assigned region and serving as the front-facing DQA contact with Recovery Partners to resolve any partner concerns.

Responsibilities

• Provide support to Account Managers and facilitate obtaining donor chart information to accurately complete donor chart reviews.
• Organize donor chart information and all charting follow-up to meet required chart review targets and workflow.
• Maintain accurate pending chart information lists and pending additional information.
• Ensure donors received for processing are properly identified, controlled, and meet required quality specifications and regulatory standards prior to release.
• Perform the quality review of donor records prior to Final Review and Medical Directors review for donor eligibility.
• 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.
• Understand ISO requirements, AATB, GTPs, and the Quality System Regulations as they pertain to the entire operation (e.g., nonconformities, Good Documentation Practices, calibration, equipment maintenance, product storage and identification).
• Ensure that donors with status of Pending Complete and Pending Reject are properly identified, controlled, and meet the required quality specifications for discard prior to chart completion.
• Provide input to management that facilitates the process for new, revised, and obsoleted documents (policies, procedures, forms, templates, etc.) as they pertain to the job.
• Provide mentoring and assistance to DQA Technicians.
• Lead and present ideas that are motivating, by maintaining positive support, setting a positive example, and establishing an overall objective and creative atmosphere.
• Increase productivity and revenues by optimizing processes and workflows.
• Effectively complete “other” functions that may be assigned.

Qualifications

• Bachelor’s Degree in the Life Sciences or other scientific field
• Or 2 years experience in tissue industry and/or handling medical records
• Or 1 year experience as Donor Quality Assurance Technician
• 1 year experience in Quality preferred