✦ Luna Orbit — Project & Program Management

Senior Quality Systems Engineer

at Boston Scientific

📍 Arden Hills, MN, US, 55112 Hybrid Posted March 13, 2026
Type Full-Time
Experience mid
Exp. Years 5+ years
Education Bachelor's degree in relevant field
Category Project & Program Management

This role involves leading CAPA and NCEP activities, supporting quality systems, and driving continuous improvement in a regulated medical device environment.

  • Support CAPA and NCEP activities
  • Manage quality data trending and reporting
  • Lead continuous improvement projects
  • Ensure regulatory compliance
  • Collaborate with global quality teams

Focus on quality systems, CAPA/NCEP processes, data trending, metrics reporting, and regulatory compliance within the healthcare industry, emphasizing project management and problem-solving skills.

The ideal candidate is a senior quality systems engineer with over 5 years of experience in CAPA and NCEP processes within the medical device industry. They excel in project management, data analysis, and regulatory compliance, with strong communication and leadership skills.

Bachelor's degree in relevant field5+ years CAPA/NCEP experienceExperience in medical device industryProblem-solving skillsAbility to work independently
Previous CAPA ownershipStandardized toolsInfluencing skillsVerbal and written communicationNetworking skillsProcedural document evaluation
CAPANCEPProject managementData trendingMetrics reportingQuality systemsRegulatory complianceProblem-solvingProcess improvementCommunication
CAPANCEPProject managementData trendingMetrics reportingQuality systemsRegulatory complianceProblem-solvingProcess improvementCommunication
CommunicationLeadershipOrganizationProactivityCollaborationIndependence
Industry Healthcare & Medical
Job Function Leading quality systems and CAPA processes in the medical device industry
CAPANCEPProject managementData trendingMetrics reportingQuality systemsRegulatory complianceProblem-solvingProcess improvementCAPA LeadGlobal CAPAMedical device industryQuality assuranceContinuous improvement

Less than 5 years of experience in CAPA/NCEP, No experience in medical device industry, Lack of problem-solving skills, Inability to work independently

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