Job Description
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
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Other details
Job Family
Quality Operations
Job Function
Quality
Pay Type
Hourly
Employment Indicator
Non Manager
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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.
