Quality Coordinator

Location: Cincinnati, OH
Department: Quality Systems
Employment Duration: Full Time Regular
FLSA Status: Non-Exempt
Job Code: 2019-113
Office based or Remote: Office Based

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

AtriCure is an Equal Employment Opportunity/Affirmative Action employer. 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).

 

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 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, 15 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




Agency and Third Party Recruiter Notice:

 

Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.


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