Quality Assurance Specialist - Human Tissue QA (Onsite - Kennesaw, GA)

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 Overview:

Establish and maintain Quality Systems that comply with regulations and standards.  Review all records associated with the processing of human tissue and production of medical device products.  Reduce waste and variability in processes.   Ensure that all areas identified as “Principal Responsibilities” are accomplished in an efficient and professional manner.

Responsibilities:

• Take responsibility and authority for ensuring quality assurance compliance throughout affected areas.
• Complete quality assurance record reviews on all associated medical, tissue, and distribution records.
• Review all associated monitoring records for medical device and tissue related departments.
• Maintain all quality assurance records per current requirements.
• Interface with other departments to clarify and/or correct information provided and solicit information as required.
• Develop systematic methods for completing work assignments to ensure deadlines are met and personal job commitments are accomplished.
• Understand ISO requirements, GTPs, and the Quality System Regulations as they pertain to the entire operation, i.e., nonconformities, Good Documentation Practices, calibration, equipment maintenance, tissue/product storage and identification, etc.
• Keep supervisors and associates informed of significant information, company policies and procedures as they become available, and provide such information in a manner that encourages willing cooperation and support.
• 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. 
• Increase productivity and revenues by optimizing processes, work flows, and manufacturing equipment.
• Effectively complete “other” functions that may be assigned by management.

Qualifications:

• Bachelor’s Degree in the Life Sciences or other scientific field or equivalent work experience.
• Minimum 1 year experience in Quality preferred.
• Previous experience in a regulated industry is preferred.
• Ability to lift up to 60 pounds.
• Must have excellent expression (both oral and written) and must be a goal-oriented team player with good collaborative skills and ability to work with internal and external contacts and customers.
• Must be opened-minded, flexible, and able to adapt easily and accept new ideas quickly.
• Must have the willingness to accept responsibility and the ability to influence change through sound judgment and conviction.
• Maintain the ability and interest in being on the job every day as required by current attendance policies.