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 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 maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).