Job Opening: Quality Coordinator
- Company
- Atricure, Inc.
- Location
- Mason, OH
- Posted on
- May 18, 2024
Quality Coordinator
Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America
Req #2042
Thursday, May 9, 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 SUMMARY:
This position will be responsible for ensuring the AtriCure Document Control System is in compliance with domestic and international medical device quality system regulations. The Quality Coordinator is able to answer daily quality questions to in regard to MasterControl and document control. In the role of the 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.
ESSENTIAL FUNCTIONS OF THE POSITION:
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
Assisting with execution of updates of ERP system following release of Document Change Notices
Responsible for understanding and maintaining compliance with domestic and international medical device quality system regulations, where appropriate
Responsible for complying with all document control processes within the AtriCure Quality System.
Aide in finished product release activities as assigned
Perform Quality System activities and other company activities in addition to the above as needed
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned
BASIC QUALIFICATIONS:
High School Diploma or GED
Experience with inspection/testing
Strong computer/data entry and communication skills with an emphasis on attention to details
Problem solving/trouble shooting experience
PREFERRED QUALIFICATIONS:
Auditing Experience
Read technical Specifications
Read blueprints, drawings, specifications
OTHER REQUIREMENTS:
Ability to regularly walk, sit, or stand as needed
Ability to occasionally bend and push/pull as needed
Ability to pass pre-employment drug screen and background check
AtriCure has a