AtriCure Job - 30014502 | CareerArc
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Company: AtriCure
Location: Cincinnati, OH
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Position/Title:

Quality Coordinator

Department:

Quality

Reports To:

Quality Systems Manager

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:

The Quality Coordinator is 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 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:

  • 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
  • Ability to travel 5%

PREFERRED QUALIFICATIONS:

  • Auditing Experience
  • Read technical Specifications
  • Read Blueprints, Drawings, Specifications

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, occasionally over 25 pounds
  • Ability to pass pre-employment drug screen and background check


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