• Quality Engineer, Operational Support

    Posting Date 2 months ago(3/11/2019 8:29 AM)
    Requisition ID
    Job Location(s)
    Bloomington IN United States
    Shift Type
    Position Type
    Full Time
    Cook Inc.
  • Overview

    The Operational Support Quality Engineer at Cook Inc. serves as the quality representative of operational support subsystems: environmental monitoring, facilities, calibration, quality testing laboratories, information technology, and data control.  The Quality Engineer fulfills the role of both contributor and independent reviewer of key operational outputs.


    - Provide quality support for environmental monitoring, including impact assessment of environmental excursions and appropriateness of resuming production after an excursion
    - Facilitate development and implementation of environmental controls (qualification, sampling plans, trending, etc)
    - Assist with planning facility expansions and modifications
    - Review Software Qualifications as needed
    - Perform investigation of product nonconformances and complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
    - Execute risk assessment as needed and facilitate development and completion of risk file documentation
    - Conduct risk-based decision making and effective resolution of quality-related issues
    - Perform work per external and internal quality standards
    - Interface with internal and external groups on quality-related 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, operations, 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
    - Plan, review, and approve change requests

    - Must work and interact effectively and professionally with and for others throughout various levels of the global organization.

    - Must strictly adhere to safety requirements.

    - Maintain regular and punctual attendance.

    - Must maintain company quality and quantity standards.

    - Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.

    - Ability to remain calm and receptive in fast paced situations.



    - Bachelors degree in engineering or scientific discipline or equivalent experience
    - Masters degree preferred
    - Demonstrates knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971) preferred
    - Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
    - Proficiency in statistical, quality, and continuous improvement methods and tools preferred
    - Proficiency in Microsoft Office software (Word, Excel, PowerPoint, and Outlook) is required
    - Strong organizational skills required
    - Critical thinking and attention to detail required
    - Excellent verbal communication skills and technical writing required


    - Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.




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