Sr. Design Quality Engineering - Irvine - Simarn Solutions

    Simarn Solutions
    Simarn Solutions Irvine

    6 hours ago

    $125,000 - $185,000 (USD) per year *
    Description

    About the job Sr. Design Quality Engineering
    Sr. Design Quality Engineering
    Location: Irvine, California
    Job Type: C2C | Hybrid
    Pay Rate: $50/hr
    Industry: Manufacturing / Medical Devices
    End Date: 01-Jan-2026
    Job Description
    We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance, supporting risk management activities, and leading verification and validation processes. The role requires strong collaboration with cross-functional teams, hands-on involvement in design control, and the ability to resolve quality issues through structured problem-solving and risk-based approaches.
    Responsibilities

    • Ensure quality engineering activities meet regulatory and internal standards.
    • Create and maintain product risk management documentation (Risk Plans, DFMEA, Risk Assessments, Risk Reports).
    • Support development and execution of V&V plans, protocols, and reports.
    • Perform Test Method Validation and process validation (PFMEA, IQ, OQ, PQ).
    • Use statistical tools such as Minitab for data analysis.
    • Oversee product testing to ensure compliance with applicable requirements.
    • Apply Design Control principles to support sustaining engineering and product updates.
    • Resolve quality issues and support design changes with cross-functional teams.
    • Apply risk management techniques to identify and mitigate product risks.
    • Use structured problem-solving methodologies to address product and process challenges.
    • Prepare technical documentation, reports, and presentations for stakeholders.
    Required Qualifications
    • Experience with quality engineering in manufacturing or medical device environments.
    • Strong knowledge of design control, risk management, and process validation.
    • Hands-on experience with DFMEA, PFMEA, V&V activities, and statistical tools (Minitab).
    • Ability to support sustaining engineering and design updates.
    • Strong analytical, communication, and problem-solving skills.
    • Experience collaborating with engineering, manufacturing, and quality teams.
    * This salary range is an estimation made by beBee
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