DQA Technician

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.
Our Austin facility comprises a diverse team, including quality engineers, sustaining engineers, production associates, IT professionals, and various other experts dedicated to supporting the production of our On-X Mechanical Heart Valves.
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 Overview: The DQA Tech will ensure all donor information received is properly handled in an efficient, timely, and professional manner.
Ensure all records associated with donor/tissue products and processes are properly identified, controlled, and tracked within the Donor Quality Assurance (DQA) file room.
Ensure review of external Recovery Partner forms are complete and attached.
Perform initial review of incoming donors to assess for infectious disease testing needs, internal pathology services, and accurate demographic information.
With minimal supervision, ensure all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner to support Artivion.
Position Responsibilities: Use multiple systems and programs to process donor information received from external Recovery Partners, other processors, and laboratories to be inputted into the appropriate donor record.
Perform data entry tasks for donor records, including but not limited to serology and culture entry.
Maintain DQA File room, including organizing donor/tissue product information, periodically archiving Complete / Rejected charts, and maintaining relevant databases.
Build a working relationship with Human Tissue Quality Assurance to gather and organize graft records.
Scan Certificates of Assurance to support Customer Service.
Review Recovery Partner forms that are submitted to DQA.
Complete review of all Rejected charts and update the donor chart status as appropriate.
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, i.
e.
, nonconformities, Good Documentation Practices, calibration, equipment maintenance, product storage and identification, etc.
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.
Ability to 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: High School Diploma or equivalent.
1-2 years of relevant experience Organized, detail-oriented, and adaptable.
Capable of following instructions and working without direct supervision.
Good typing and communication skills, knowledge of general office procedures.