Quality Systems Coordinator

Quality System Maintenance Assistant

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. 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.

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 Summary

This position will be responsible for assisting in the maintenance of the validated state of the Quality System and work on project teams that enhance AtriCure's Quality System (QMS). They will participate in audits of the QMS and ensure externally identified changes are appropriately executed through AtriCure's processes.

Essential Functions Of The Position

• Assists with special projects for the Quality System, including implementation of new regulations, product obsolescence and other projects identified throughout the lifecycle of commercialized product.
• Participate in cross-functional activities with input from Regulatory Affairs and commercial teams to ensure all requirements are understood and fulfilled when introducing a change to an existing system, regardless of geographic region.
• Participate in Quality Systems Internal Audits, including training to become certified as a lead QMS auditor.
• Support external Quality Systems Audits through functions such as backroom lead.
• Work directly with other functions of the Quality team to ensure needs are met and incorporated into any integration or expansion plans.
• Identify and lead continuous improvements through the AtriCure CAPA process.

Additional Essential Functions Of The Position

Basic Qualifications

Preferred Qualifications

Other Requirements

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to m