✦ Luna Orbit — Software Engineering

Quality Engineer I

at Owens & Minor

📍 Louisville, KY Unknown 💰 $45K – $83K USD / year Posted March 13, 2026
Salary $45K – $83K USD / year
Type Full-Time
Experience entry
Exp. Years 0+ years
Education Not specified
Category Software Engineering

This role supports the implementation and maintenance of quality management systems within a healthcare product environment, ensuring compliance and continuous improvement.

  • Supports QMS programs
  • Ensures compliance in medical device distribution
  • Defines quality objectives for KPIs
  • Maintains SOPs and Work Instructions
  • Assists with regulatory audits

Focuses on quality processes, SOPs, regulatory standards, and risk management in a healthcare setting.

The ideal candidate is an entry-level quality engineer with a strong understanding of quality management systems, medical device regulations, and process documentation. They should possess excellent communication skills and attention to detail to support compliance and quality improvement initiatives.

Supports and drive Quality Management System (QMS) programsSupports compliance in distributionrepackagingrelabeling of medical devicesSupports quality objectives for KPIs
Experience with medical device regulationsKnowledge of SOPs and Work Instructions
Regulatory compliance toolsQuality management software
Quality Management SystemQMSSOPsWork InstructionsRegulatory ComplianceQuality MetricsRisk ManagementChange ManagementMedical DevicesHealthcare
Quality Management SystemQMSStandard Operating ProceduresSOPsWork InstructionsWIsRegulatory ComplianceQuality MetricsRisk ManagementChange ManagementManagement Reviews
CommunicationTeamworkProblem-solvingAttention to detailCollaboration
Industry Healthcare & Medical
Job Function Quality assurance and compliance support in healthcare manufacturing
Quality Management SystemQMSStandard Operating ProceduresSOPsWork InstructionsRegulatory ComplianceQuality MetricsRisk ManagementChange ManagementManagement ReviewsMedical DevicesHealthcareQuality AssuranceProcess ImprovementHealthcare Regulations

Lack of experience with medical device quality systems, No understanding of healthcare regulatory requirements

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