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    Manufacturing Quality Engineer 2 - Bloomington, United States - Cook Group

    Cook Group
    Cook Group Bloomington, United States

    2 days ago

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    Description

    Overview:


    The Manufacturing Quality Engineer serves as the lead quality representative of assigned product lines for new product development, day to day manufacturing support, non-conformance, and acts as the independent review function.

    The Manufacturing Quality Engineer supports additional process such as Supplier Quality, Internal Audit, CAPA, and Post Market Surveillance. The Manufacturing Quality Engineer fulfills the role of both contributor and independent reviewer for their assigned product lines.

    Responsibilities:
    Perform work per external and internal quality standards.

    • Perform independent review function per external and internal quality standards.
    • Interface with internal and external groups on qualityrelated issues.
    • Be the voice of quality for daily manufacturing in assigned departments by partnering with Operations and Production Engineering and providing guidance on issues in line with external standards, internal standards, and best practices.
    • Support product development and transfer to manufacturing.
    • Facilitate development and implementation of production processes and controls. (e.g. qualification, process capability, sampling plans, validation, etc.)
    • Assist with investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.
    • Own quality improvement tasks in assigned departments.
    • Plan, draft, and route change requests as necessary.
    • Execute risk assessment as needed and facilitate development and completion of risk file documentation.
    • 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 engineering, production, clinical, and regulatory affairs.
    • Provide leadership in the understanding of medical device regulations and best practices.
    • 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 ensure compliance to FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

    Qualifications:
    Bachelors degree in engineering

    • Knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO is preferred but will consider a candidate with quality experience from any regulated industry.
    • 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.
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