Supplier Quality Engineer

Stark Pharma

  • Burnsville, MN
  • 4 days ago

    Highlights

    OverviewLocation: Burnsville, MNDuration: 9+ Month Contract (Potential Extension)Start Date: ASAPPosition OverviewWe are seeking a Supplier Quality Engineer with medical device industry experience to support supplier quality management, component qualification, and supplier development activities. This role will be responsible for ensuring suppliers consistently meet quality, regulatory, and performance requirements, with a strong focus on PCB components, testing methodologies, and supplier qualification processes.

    Numbers & Facts

    LocationBurnsville, MN

    Description

    OverviewLocation: Burnsville, MNDuration: 9+ Month Contract (Potential Extension)Start Date: ASAPPosition OverviewWe are seeking a Supplier Quality Engineer with medical device industry experience to support supplier quality management, component qualification, and supplier development activities. This role will be responsible for ensuring suppliers consistently meet quality, regulatory, and performance requirements, with a strong focus on PCB components, testing methodologies, and supplier qualification processes.Key ResponsibilitiesLead supplier selection, qualification, and performance monitoring activitiesManage supplier onboarding and component qualification processes, including PPAP submissions and approvalsPartner with suppliers to establish and evaluate PCB testing methods, inspection criteria, and acceptance standardsReview and validate functional, electrical, and verification testing processes for PCB components and assembliesEnsure supplier processes and products meet design, quality, and regulatory requirementsConduct supplier audits (onsite and remote) and drive corrective and preventive actionsSupport development, validation, and continuous improvement of test methods and inspection processesCollaborate with Engineering, Manufacturing, Quality, and Supply Chain teams to support design transfer and manufacturing readiness activitiesParticipate in DFMEA and risk management activities to identify and mitigate supplier-related risksMonitor supplier quality performance metrics and drive continuous improvement initiativesRequired QualificationsBachelor's degree in Engineering, Quality, or related technical disciplineExperience in Supplier Quality Engineering within the medical device industryStrong knowledge of supplier qualification, component validation, and PPAP processesExperience with PCB components, assemblies, and testing methodologiesExperience conducting supplier audits and managing supplier corrective actionsUnderstanding of design verification, validation, and risk management processesStrong problem-solving, communication, and project management skills#J-18808-Ljbffr

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