Quality Engineer II - Holdrege - Intellectt Inc

    Intellectt Inc
    Intellectt Inc Holdrege

    2 days ago

    Pharmaceutical / Bio-tech
    Description

    Immediate Hiring for Quality Engineer II Holdrege, NE (Onsite Only) - Full time

    Shift: 1st Shift

    Hours: 40 hours/week (Overtime as approved by manager)

    Salary Range: $65,000 – $75,000

    Position Summary

    Reporting to the Quality Engineering Leader, the Quality Engineer II supports both New Product Development (NPD) and Sustaining Engineering activities for medical devices. This role ensures compliance with corporate quality policies, design control requirements, and regulatory standards while driving continuous improvement across operational processes.

    The Quality Engineer II plays a key role in product lifecycle activities—from concept through launch and post-market support—ensuring product quality, process control, and regulatory compliance.

    Key Responsibilities

    New Product Development (NPD)

    • Support projects from product inception through launch and maintenance.
    • Ensure compliance with design controls and regulatory requirements.
    • Apply quality engineering tools such as:
    • Root Cause Analysis
    • FMEA
    • Risk Mitigation
    • Process Validation
    • DOE (Design of Experiments)
    • Measurement Systems Analysis
    • Sampling Plans
    • Control Plans
    • Provide quality engineering guidance to cross-functional project teams.
    • Approve validation protocols, reports, and change control documentation.

    Sustaining Engineering

    General Responsibilities

    • Represent Site Quality on product development and sustaining engineering teams.
    • Collaborate with quality management, operations, suppliers, and internal stakeholders.
    • Apply sound quality assurance principles and moderate-level technical knowledge to resolve routine to moderately complex issues.
    • Determine resource needs for assigned initiatives and support plant-level product projects.

    Basic Qualifications

    • Bachelor's degree in Engineering (Industrial, Mechanical, or related field).
    • 3+ years of Quality Engineering experience, including validation responsibilities.
    • Strong knowledge of validation processes in medical devices.
    • Demonstrated experience with statistical analysis and structured problem-solving methodologies.
    • Proficiency in:
    • Minitab (or similar statistical software)
    • Microsoft Word, Excel, and Project

    Preferred Qualifications

    • Strong understanding of failure analysis, test methods, and engineering tolerances.
    • Knowledge of regulatory standards including:
    • 21 CFR 820
    • 21 CFR 210 & 211
    • ISO 13485
    • Six Sigma Certification (preferred)
    • ASQ Certified Quality Engineer (CQE)
    • Certified Quality Auditor (CQA)
    • Project Management experience
    • Excellent verbal, written, and interpersonal communication skills

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