• Quality Engineer

    Location US-MO-Harrisonville
    Job ID
    2018-11273
    Function
    Manufacturing & Production
  • Overview

    Quality Engineer


     


    Summary 


    The Quality Engineer ensures the executional excellence of product launches by providing timely (as early as Stage 1, i.e., concept stage) manufacturing process-specific input; acting as the receiving point of Technology Transfer and ensuring proper Qualification/Validation of equipment, formulas and processes on an ongoing basis.

    Responsibilities

    Role Accountabilities and Responsibilities
    • Become an expert in the fundamentals of the relevant manufacturing equipment & processes
    • Perform Statistical Process Control (SPC) tests in order to develop a line capability database (manufacturing and packaging)
    • Provide Plant-relevant input into FMEA’s, lessons learned, and DfM
    • Liaison with R&D Process, Product, & Package Development & Analytical to design appropriate tests and scale-up trials
    • Provide recommendations for opportunities for cost savings and efficiency gains
    • Responsible for the ‘Receiving End’ of the Technology Transfer Process as well as input to the process during development
    • Responsible for process qualifications of minor changes to formulations (G2G projects, raw material qualifications, etc)
    • Project Management Skills
    • Assist/facilitate root cause analysis and problem-solving

    Qualifications

    Education and Experience
    • BS/MS degree in related field (Quality Engineering certification desirable)
    • Minimum of 5 years experience in the consumer products, medical device, and/or pharmaceutical industries
    • Experience working in a plant environment with manufacturing, contractors and suppliers.

    Skills and Competencies
    • Knowledge of QE, auditing of manufacturing operations for medical devices, OTC and /or pharmaceutical industries.
    • Lean Six Sigma Black Belt a plus
    • Experience effectively partnering with outside contractors.
    • High initiative with demonstrated results achievement and orientation.
    • Excellent influence, persuasion, verbal and written communication skills required.
    • Trained auditor in GMP, and ISO 9001 or 13485


     


    Equal Opportunity Employer/Veterans/Individuals with Disabilities

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