Quality Assurance Specialist

Location: Atlanta, GA, United States of America


ZOLL Itamar is an innovative medical device technology company that focuses on the development and manufacturing of Home Sleep Apnea Tests to aid in the diagnosis of respiratory sleep disorders. Our core product is the WatchPAT®️ family, a revolutionary FDA-cleared portable home sleep apnea test device, that is based on propriety signal and analysis. 80% of patients who have sleep apnea are undiagnosed.  We are committed to reach those undiagnosed patients and provide testing to promote wellness and enhance overall quality of life.  

WatchPAT®️ is commercially available within major markets including the U.S., Japan, and Europe, and is the leading home sleep apnea test in the US. ZOLL Itamar’s corporate headquarters, research and development and manufacturing are located in Israel with U.S. headquarters based in Atlanta, GA.

Position Summary:

The Quality Assurance Specialist will support Quality Activities according to Yearly Quality Plan with compliance to ISO13485 for Distributors. Manage the Quality Management System (QMS), and Quality Training following key performance indicators. This will include responsibility for Document control system, Process change control management, non-conforming management MRB, Supplier Quality control, generating reports to management and running Quality System Management reviews.

Primary Responsibilities:

  • Responsible for Quality management system and controlling ZOLL Itamar documents according to procedures and regulatory requirements.

  • Maintain Good Distributor Practice (GxP) in Atlanta facility.

  • Non-Conforming, MRB and other Material disposition

  • Manage and follow up on yearly Quality Plan according to ISO13485 and other relevant standards and regulations.

  • Quality and compliance training initiation and follow up.

  • Responsible for ongoing quality and compliance training

  • Uploading and maintaining documents on PLM and company servers. Distribution of controlled documents to employees.

  • Maintaining environment control

  • Follow up and maintenance calibration.

  • FU on Vendor qualification

  • Maintaining Employees Training records


  • Bachelor's degree

  • 2 years in a medical device or pharmaceutical production company in Quality, Documentation or Regulatory role

  • MS Office, ERP environment

  • Great attention to detail, meticulous, and process oriented

  • Good written and verbal communication skills  

  • Team player

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:

  • The employee is required to sit – perhaps at long intervals of time

  • The employee is required to work on a computer for long intervals.


This position does not include travel.

Supervisory Reports:

This position has no direct reports.