• Quality Engineer

    Posting Date 1 month ago(5/17/2019 1:31 PM)
    Requisition ID
    2019-5916
    Job Location(s)
    Bloomington IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Medical Inc.
    Category
    Quality
  • Overview

    The Quality Engineer at Cook Medical is responsible for executing and/or monitoring key processes in support of the Quality Management System: auditing; complaint investigation; corrective and preventive action (CAPA); control of non-conformances; document, data, and change control; process control; risk management and supplier quality management. The Quality Engineer fulfills the role of Independent Reviewer of many key process outputs.

    Responsibilities

    • Perform work per external (ISO 13485:2016) and internal quality standards
    • Interface with internal and external groups on quality-related issues
    • Facilitate development and implementation of process controls (e.g. qualification, process capability, sampling plans, validation, etc.)
    • Perform investigation of non-conformance/complaint, root cause analysis, monitoring/trending of process, and escalation of identified issues
    • Plan, review, and approve change orders
    • Execute risk assessment as needed and facilitate development,  completion and organization of risk file documentation
    • Conduct risk-based decision making and effective resolution of issues
    • Lead or support CAPAs as necessary
    • Maintain accurate and timely reports and records
    • 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, warehousing, information technology, customer support, customer relations and/or regulatory affairs
    • Manage conflict resolution as it relates to technical situations
    • Utilize strong organizational skills, critical thinking, and attention to detail

    Qualifications

    • Bachelor's degree in a scientific discipline or experience of such kind and amount as to provide a comparable background
    • Demonstrates knowledge of medical device regulations (21CFR820) and risk management
    • Proficiency in statistical, quality and continuous improvement methods and tools
    • Proficiency in the Microsoft Office software (Word, Excel, PowerPoint, and Outlook)
    • Professional certification (e.g. ASQ, Six Sigma, etc.) preferred 

    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 warehouse
    • Sitting for extended periods
    • Utilizes close visual acuity for working with computers and equipment
    • Occasional travel may be required

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