Sr Supplier Qual Engineer

Artech LLC

  • Fort Worth, TX
  • 26 days ago

    Highlights

    Inspection & Metrology: Develop inspection methods with suppliers/incoming inspection/metrology; validate test methods; establish acceptance sampling plans . Medical Device Quality: Experience with medical-device quality systems and regulated manufacturing; Client quality system experience preferred.

    Numbers & Facts

    LocationFort Worth, TX

    Description

    Job Title: Sr Supplier Qual Engineer
    Job ID: 28285
    Location: 4620 N Beach St Fort Worth Texas 76137
    Duration:12 months


    Top 3 Must-Haves

    1. PPAP / Part Qualification: Control Plans, PFMEA, Risk Management, IQ/OQ/PQ, Process Capability, First Article Inspection (FAI).
    2. Inspection & Metrology: Develop inspection methods with suppliers/incoming inspection/metrology; validate test methods; establish acceptance sampling plans.
    3. Medical Device Quality: Experience with medical-device quality systems and regulated manufacturing; Client quality system experience preferred.

    Key Responsibilities

    • Qualify and manage suppliers for NPI/NPD and production parts.
    • Manage PPAP deliverables, including Control Plans, PFMEA, IQ/OQ/PQ, process capability and FAI.
    • Support and maintain Approved Supplier List (ASL), supplier selection, segmentation, agreements and audits.
    • Develop/validate inspection and test methods with suppliers, Incoming Inspection and Metrology.
    • Establish acceptance sampling plans and inspection requirements.
    • Review/approve engineering/change orders affecting suppliers or parts.
    • Investigate and disposition non-conforming material (NCM).
    • Resolve supplier quality issues and drive corrective actions/improvements.
    • Evaluate supplier processes/performance and provide feedback.
    • Lead or support SQE projects and provide guidance/coaching to junior team members.

    Required Qualifications

    • Bachelor’s degree + 4+ years relevant experience, OR advanced degree + 2+ years.
    • Strong Supplier Quality Engineering experience.
    • Medical-device/regulated manufacturing quality experience.
    • Strong knowledge of:
      • PPAP
      • Control Plans
      • PFMEA / Risk Management
      • IQ/OQ/PQ
      • Process Capability / SPC
      • FAI
      • Inspection & Test Method Validation
      • Metrology
      • Acceptance Sampling
      • Supplier Qualification/NPI
      • NCR/NCM and supplier corrective actions
      • Change Orders
    • Strong communication, problem solving and cross-functional/vendor management skills.
    • Onsite Fort Worth availability strongly preferred.

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