• Quality Engineer, Non-Conformance

    Posting Date 1 month ago(10/7/2019 9:55 AM)
    Requisition ID
    2019-6960
    Job Location(s)
    Bloomington IN United States
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Quality
  • Overview

    The Quality Engineer, Non-Conformance at Cook Incorporated serves as the quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.

    Responsibilities

    • Perform work per external and internal quality standards
    • Interface with internal and external groups on quality-related issues
    • Perform investigation of product non-conformances and/or processes
    • Conduct Risk-based decision making and effective resolution of issues
    • May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)
    • Manage conflict resolution as it relates to technical situations
    • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
    • Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

    Qualifications

    • Bachelor's degree in Engineering or a Technical Life Science degree
    • Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
    • Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
    • Proficiency in statistical, quality and continuous improvement methods and tools
    • Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required
    • Strong organizational skills
    • Critical thinking and attention to detail required
    • Excellent verbal communication skills and technical writing

     

    Physical Requirements:

    • Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
    • Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
    • Occasional travel may be required

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