C. R. Bard, Inc.

  • Supplier Quality Engineer

    Posted Date 3 weeks ago(5/31/2018 9:38 PM)
    Industry / Category
    Quality Engineering
    Job ID
    2018-11643
    Career Level
    experienced
    Division
    Bard Electronic Systems
    Relocation
    No
    Location
    US-PA-Zelienople
  • Overview

    This position is responsible for the development, documentation, and management of Supplier Quality Control processes as required supporting facility/division/corporate quality objectives. This position will lead both Supplier Quality Engineering in the areas of DfX, supplier development, and component qualifications. This individual will be also be responsible for supplier audits, owning and maintaining the Approved Supplier List (ASL) and for monitoring and reporting on supplier performance issues. The Supplier Quality Engineer will manage SCARS and support Operations and the Material Review Board as required.

    Essential Job Functions

    • Actively engage with product development teams and suppliers to drive DfX, part qualification requirements and control planning activity
    • Work with design and supplier to develop critical to quality criteria for purchased component and/or subassemblies
    • Proactively work with suppliers to understand purchasing and design specifications to drive first time right receipt of component and subassemblies for the manufacturing life of the product
    • Perform supplier development activity as required
    • Understand the critical to quality requirements of existing purchased components or subassemblies to drive root cause analysis or supplier corrective actions
    • Lead Supplier Quality Auditing processes for the BES-Dymax Quality Assurance Team
      • Create and Maintain supplier audit schedules, agenda’s, and reports
      • Drive root cause and permanent corrective action and all supplier non-conformances
    • Sustain the BES-Dymax (ASL) approved supplier list
      • Consolidate ASL to improve quality, remove redundancy, and cost reduction
      • Maintain a constant up to date ASL approvals, limited approvals, and disapprovals
      • Lead and ensure the completion of all new supplier/part approval requirements:
        • Qualification Audits / Assessments
        • Design Qualification protocols and reports
        • Part Qualifications: i.e. (FAI) first article inspections, Capability studies, Process Control Plans, Gage R & R, Process validation (IQ, OQ, PQ), and process flow charts
    • Provide supplier related quality assurance sustaining engineering support to established product lines
    • Assist Material Review Board in the investigation of material defects and failures
    • Participate on New Product Development and Project Transfer teams to ensure the completion of all approval and transfer of suppliers into the BES-Dymax supplier management system
    • Assist Procurement, Materials and Engineering in the selection of new suppliers
    • Track supplier performance and prepare and issue monthly reports of supplier and material quality performance, issues, and actions
    • Issue Supplier Corrective Action Requests as appropriate in response to detected supplier quality trends and follow-up with suppliers on root cause investigation and permanent corrective action

    Basic Qualifications

    Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc) 3-5 years of experience in the manufacture of Electro-Mechanical devices 1-3 years experience in an FDA regulated Medical Device Manufacturing environment preferred. Team leader / player comfortable communicating with broad audiences A solid understanding of the FDA QSR and/or ISO 9000/ISO 13485 Quality System Requirements Specifically in design controls and design transfer and supplier controls Excellent oral and written communication skills to prepare written technical plans and reports in support of engineering changes, product or process validations, and component qualifications Strong project planning skills and a strong focus on meeting customer needs ASQ Certified Quality Engineer, a plus ASQ Certified Quality Auditor, a plus

    Education and/or Experience

    Bachelors Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
    3-5 years of experience in the manufacture of Electro-Mechanical devices
    1-3 years experience in an FDA regulated Medical Device Manufacturing environment preferred.

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