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 system following release of Document Change Notices
• Responsible for understanding and ensuring compliance with all domestic and international medical device quality system regulations, where appropriate
• Responsible for ensuring all document control processes are compliant to AtriCure Quality System and Company Policies
• Responsible for administering external standards management as assigned
• Responsible for administering electronic record storage as assigned
• Assist in Internal Auditing as assigned
• Aide in finished product release activities as assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable worksite attendance
• 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:

• Bachelor’s degree in Business, Biosciences or relevant major or demonstrated equivalent combination of education, training and experience
• Auditing Experience
• Read technical Specifications
• Read Blueprints, Drawings, Specifications
• Experience in a document management software such as Master Control
• Ability to travel 5%

PREFERRED QUALIFICATIONS:

• Bachelor’s Degree in Business, Biosciences, or relevant major
• Auditing Experience
• Read technical Specifications
• Read Blueprints, Drawings, Specifications
• Experience in a document management software such as Master Control

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as required
• Ability to occasionally bend and push/pull
• Ability to regularly lift up to 25 pounds
• Ability to pass pre-employment drug screen and background check

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