Sr. Supplier Quality Engineer

STAFTONIC LLC

  • Minneapolis, MN
  • 3 days ago
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    Skills

    • Change Controlunmatched
    • Change Requests/Ordersunmatched
    • Continuous Improvementunmatched
    • Documentationunmatched
    • FDA (Food and Drug Administration)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Medical Equipmentunmatched
    • Problem Solving Skillsunmatched
    • Process Capabilityunmatched
    • Process Validationunmatched
    • Product Managementunmatched
    • Product/Service Launchunmatched
    • Purchasing/Procurementunmatched
    • Quality Engineeringunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Risk Analysisunmatched
    • Root Cause Analysisunmatched
    • Sales Qualificationunmatched
    • Strategic Planningunmatched
    • Team Playerunmatched
    • Vendor/Supplier Evaluationunmatched
    • Vendor/Supplier Managementunmatched
    • Vendor/Supplier Planningunmatched
    • Vendor/Supplier Quality Managementunmatched

    Description

    Senior Recruiter at Staftonic, Passionate about connecting great people with great opportunitiesPosition: Sr. Supplier Quality EngineerLocation: Minneapolis, MNDuration: Long-Term ProjectKey Responsibilities:Lead supplier qualification, evaluation, and management for new product introduction and commercialization.Develop and execute supplier control strategies, qualification plans, and risk assessments.Review and approve supplier change requests, material specifications, and documentation to ensure compliance with internal and regulatory standards.Partner with Design, Manufacturing, Quality, and Regulatory teams to ensure supplier readiness and robust validation of purchased materials and components.Drive root cause analysis and implement effective CAPAs to address supplier quality issues.Support continuous improvement initiatives to enhance supplier performance and process capability.Qualifications:Bachelor's degree in Engineering, Quality, or a related discipline.Minimum 5 years of experience in Supplier Quality or Quality Engineering within a regulated industry (Medical Device experience strongly preferred).Strong working knowledge of ISO 13485 , FDA QSR , and supplier quality management systems.Hands‑on experience with supplier qualification , process validation (IQ/OQ/PQ) , and change control .Excellent problem‑solving, communication, and cross‑functional collaboration skills.Seniority levelMid‑Senior levelEmployment typeContractJob functionMedical Equipment Manufacturing#J-18808-Ljbffr

    Numbers & Facts

    LocationMinneapolis, MN

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