• Quality Engineer- Spencer

    Posting Date 4 weeks ago(6/26/2018 3:15 PM)
    Requisition ID
    2018-3797
    Job Location(s)
    Spencer IN United States
    Travel
    Less than 10%
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Spencer
    Category
    Quality
  • Overview

    The Quality Engineer at Cook Inc. serves as the lead 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
    • Support product development and transfer to manufacturing
    • Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)
    • Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
    • Plan, review, and approve change requests
    • Execute risk assessment as needed and facilitate development and completion of risk file documentation
    • Conduct Risk-based decision making and effective resolution of issues
    • Lead or support CAPAs as necessary

    • May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)
    • Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
    • Provide leadership in the understanding of medical device regulations and best practices
    • Manage conflict resolution as it relates to technical situations
    • Must work and interact effectively and professionally with and for others throughout various levels of the organization
    • Must strictly adhere to safety requirements

    Qualifications

    • Bachelors degree in a scientific discipline or equivalent experience
    • 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

    • Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

     

    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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