Field Assurance Associate

Description

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 :

Under the direction of the Sr. Manager, Post Market Quality and with minimal supervision, the Field Assurance Associate will assist with maintaining the Field Assurance Program to ensure compliance to all safety, regulatory and corporate requirements. Will ensure compliance to all U.S. and International regulations regarding the handling and reporting of Customer / Product Complaints and Adverse Events. Will ensure that areas identified as "Principal Responsibilities" are accomplished in an efficient and professional manner.

Responsibilities :

• Will enter data of reported event into electronic complaint handling system.
• Will develop, implement, revise, and follow all Field Assurance procedures to ensure processes are in place for the timely and accurate receipt, logging, analysis and response to Customer / Product Complaints.
• Will review Customer Complaints for validity and ensure complaints are processed efficiently in compliance with all Field Assurance procedures.
• Will ensure Customer Complaint investigation activities and regulatory reporting complies with all applicable local, state, federal and international reporting requirements for Complaint handling and Adverse Event reporting.
• Will perform administrative tasks associated with Complaint investigations and documentation to ensure Complaints are accurate, comprehensive, and completed in a timely manner including submissions and tracking of formal reports to regulatory bodies.
• Will perform final review of the investigations performed by various Artivion departments for accuracy, root cause analysis and identification of potential Corrective Actions / Preventative Actions (CAPA's).
• Will interact with Healthcare workers and Artivion employees regarding Customer complaints and Adverse Events.
• Will coordinate and lead multidisciplinary teams during in-depth investigations of Adverse Events and / or Customer Complaint and where noted identify trends.
• Will provide guidance and education regarding Customer Complaint processing, Medical Device Reports, complaint reportability, complaint scenarios, sample return procedures and regulatory compliance.
• Will maintain the Field Assurance Complaint Laboratory, including but not limited to routine cleaning, stocking supplies and equipment repair requests.
• Will be knowledgeable on all applicable standards, regulations and procedures related to the handling of Customer Complaints and / or Adverse Events for both tissues and devices.

Qualifications :

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.

For further information, please review the Know Your Rights notice from the Department of Labor.