Quality Coordinator Mason HQ, 7555 Innovation Way, Mason, Ohio, United States of America Req #2042 Tuesday, April 16, 2024 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. 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 in recordkeeping and/or document management. 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 Experience in a document management software such as Master Control 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 #LI-AM1 Other details Job Family Quality Operations Job Function Quality Pay Type Hourly Employment Indicator Non Manager Share this job: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.