Quality Assurance Specialist II - 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 products and make final decisions to release product for distribution. Exercise discretion to reduce waste and variability in processes. Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations.

Responsibilities:

• Complete all associated human tissue record reviews and make final decisions to release product based on review and discretion.
• Review all associated monitoring records for human tissue production departments.
• Increase productivity and revenues by optimizing processes and work flows through experience and knowledge obtained.
• Initiate and provide consultation to management for cause-identification and problem-resolution for various types of quality investigations.
• Work with management to formulate and use authority to implement new operating practices to improve processes.
• Engage with other applicable personnel to clarify, collaborate, and/or correct the information provided, and to solicit required information.
• Develop systematic methods for completing work assignments to ensure deadlines are met and personal job commitments are accomplished.
• Inform supervisors and associates of significant new information, company policies and procedures as they become available, and provide such information in a manner that encourages willing cooperation and support.
• Perform process and procedure audits to ensure compliance, and where necessary, initiate the activity required to implement 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.
• 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 2 years' experience in Quality preferred.
• Previous experience in a regulated industry is preferred.
• 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.