Job Information
Atricure, Inc. Senior Quality Coordinator in Mason, Ohio
Senior Quality Coordinator Cincinnati, OH, USA * Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America Req #2116 Monday, June 3, 2024 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. Position/Title: Senior Quality Coordinator Department: Quality Reports To: Quality Systems Manager or Director, Quality Systems AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. POSITION SUMMARY: This position will ensure the AtriCure Document Control System is compliant with domestic and international medical device quality system regulations. The Senior Quality Coordinator will assist in the management and establishment of policy in the document control and record retention systems. The Sr. Quality Coordinator can answer daily questions for the AtriCure organization in regard to MasterControl, record retention and document control. In the role of the Sr. Quality Coordinator, this person will work with the entire AtriCure organization to ensure compliance with the AtriCure Quality System and will be responsible to report to management issues revolving around quality system compliance. The Sr. Quality Coordinator is responsible to identify and implement state-of-the-art solutions for document control, records management, and external standards maintenance/administration. ESSENTIAL FUNCTIONS OF THE POSITION: Responsible for leading or assisting in configuration management of the quality software system Responsible for identifying and implementing process improvements to the document control system Responsible for processing Document Change Notices through the quality system Responsible for processing Data Control and Engineering Protocols and Reports through the quality system Responsible for Quality Systems Records filing, maintenance, and retention of all files (e.g. design history files, device history records, and other quality system records) per domestic and international regulatory requirements Responsible for execution of updates of ERP sy