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    Senior Quality Engineer - Cleveland, United States - BioTalent

    BioTalent
    BioTalent Cleveland, United States

    1 week ago

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    Description

    BioTalent are proud to represent a world leading Healthcare and Medical Device pioneer on the search for an Senior Quality Engineer to join their renowned site in Mississippi.

    The following information aims to provide potential candidates with a better understanding of the requirements for this role.

    They are seeking an experienced Senior Quality Engineer to perform equipment qualification, test method and process validation activities to ensure regulatory compliance at all times.

    This role will offer you:

    • A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save lives.
    • A great opportunity to develop your career within a company that provides continuous career and development opportunities.
    • The opportunity to take on more project lines at the site

    You will be Responsible for:

    • Driving quality compliance through equipment qualification, test methods and process validation activities
    • Using Lean, problem solving, process control, and project management tools to maintain operational excellence
    • Acting as an SME for CSV Validation processes.
    • Collaborate with cross-functional teams, contractors, and vendors
    • Responsible for investigations and CAPAs
    • Responsible for software validation activities in manufacturing

    You will bring the following:

    • Bachelor's Degree in Engineering or Computer Science
    • 3+ years within a similar Quality Engineering role within a highly regulated environment
    • Proficiency in applications such as Wonderware, Allen-Bradley PLC/HMI, Access, Microsoft Project
    • ASQ Certification (CQE or CSQE) or equivalent desired.
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