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    Quality Engineer - Durham, United States - Stellar Consulting Solutions, LLC

    Stellar Consulting Solutions, LLC
    Stellar Consulting Solutions, LLC Durham, United States

    2 weeks ago

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    Description

    Reporting into the Supplier Quality organization, this position supports all efforts in developing and management for all Durham, NC facility. . This position is accountable to provide leadership, development and coaching to suppliers as well as internal Supplier Quality Engineers.

    This position partners with internal stakeholders to ensure compliance to product, customer, and regulatory expectations.

    If you are considering sending an application, make sure to hit the apply button below after reading through the entire description.

    Responsibilities:

    1. Drives supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities

    2. Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions

    3. Works with suppliers to establish and maintain robust/rigorous measurement methodologies

    4. Partners with suppliers to establish and maintain controlled manufacturing processes

    5. Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering.

    6. Performs root cause analysis and corrective actions for supplier quality issues (SCARs)

    7. Performs supplier validation activities using Advanced Product Quality Planning (APQP)

    8. Performs supplier Production Part Approval Process (PPAP) activities

    Minimum Experience:

    1. Bachelor's degree in an engineering discipline is required

    2. 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

    3. Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required

    4. Lead Auditor certification is required

    5. CAPA experience- Candidate must have worked and performed root cause analysis.

    6. Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting

    Knowledge, Skills, and Abilities Requirements:


    • Strong negotiating, influence, and leadership abilities


    • Strong communication skills. Ability to communicate clearly and efficiently during difficult situations


    • Ability to work in a team environment and work through others


    • Strong analytical & problem-solving skills


    • Ability to build and maintain a team and to work in a matrix organization

    Please share resume at or call me at (XXX) XXX-XXXX

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