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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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