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Edwards Lifesciences Logo

QA Inspector - DHR review

Edwards Lifesciences

$42,000 - $57,000
Aug 13, 2025
Naperville, IL, USA
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Many structural heart patients suffer from heart failure with limited options, and Edwards' Implantable Heart Failure Management (IHFM) team is addressing these unmet patient needs through pioneering technology.

Requirements

  • Good computer skills including Microsoft Office Suite, Adobe, JDE, Ignite portal, and QMS (Quality Management System)
  • General knowledge and understanding of Edwards policies and procedures
  • Ability to read, write, comprehend, and speak English
  • Good problem-solving skills
  • Attention to detail
  • Ability to continuously focus on reviewing detailed paperwork
  • Ability to interact with contacts across the organization

Responsibilities

  • Verify DHR is ready for release and perform releases in ERP system (i.e. JDE)
  • Receive, review, and log Device History Records (DHR) with increasing complexity (e.g., rework DHRs)
  • Generate reporting to indicate status of releases
  • Work with Warehouse to resolve quantity discrepancies
  • Review NCR status and disposition prior to work order release
  • Collaborate with engineers to resolve moderately complex DHR issues
  • Initiate NCRs in QMS system and aid in investigation if needed

Other

  • H.S. Diploma or equivalent
  • 2 years previous related experience Required
  • Good communication and interpersonal relationship skills
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules)
  • COVID-19 vaccination requirement for patient-facing and in-hospital positions