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    Supplier Quality Engineer - Durham, United States - A-Line Staffing Solutions

    A-Line Staffing Solutions
    A-Line Staffing Solutions Durham, United States

    2 weeks ago

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    Description
    Job Description

    Job Description


    QUALIFICATIONS
    Drives supplier

    qualification/approval

    process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities
    Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions
    Works with suppliers to establish and maintain robust/rigorous measurement methodologies
    Partners with suppliers to establish and maintain controlled manufacturing processes
    Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering.
    Performs root cause analysis and corrective actions for supplier quality issues (SCARs)
    Performs supplier validation activities using Advanced Product Quality Planning (APQP)
    Performs supplier Production Part Approval Process (PPAP) activities

    REQUIREMENTS
    Bachelor's degree in an engineering discipline is required
    A minimum of 5 year's total experience in a Quality or Supplier Quality engineering role is required. A minimum or 3 years in Supplier Quality role desired
    Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required
    Lead Auditor certification is preferred
    CAPA experience- Candidate must have worked and performed root cause analysis.
    Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting
    Demonstrated knowledge of the Quality Engineering body of knowledge is required
    Good communication and strong writing skills are required
    Expertise with PCB, PCBA, or electro-mechanical assemblies is a plus.
    ASQ certifications are a plus (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)
    Demonstrated knowledge of DMAIC\Six Sigma and problem-solving methodologies is a required
    Candidate must be able to work autonomously and independently
    Working knowledge of any of these standards desired: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC , IEC 62304, IEC , ISO

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