Quality Systems Coordinator
Listed on 2025-12-20
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Healthcare
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Quality Assurance - QA/QC
Atri Cure, 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 Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.
Atri Cure's Atri Clip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a-standing persistent Afib patients. Atri Cure's cryo
ICE cryo
SPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit or follow us on Twitter @Atri Cure.
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 SUMMARYThis position will be responsible for assisting in the maintenance of the validated state of the Quality System and work on project teams that enhance Atri Cure's Quality System (QMS). They will participate in audits of the QMS and ensure externally identified changes are appropriately executed through Atri Cure'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 Atri Cure CAPA process.
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
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