Staff Quality Engineer - Raynham - Insight Global

    Insight Global
    Insight Global Raynham

    7 hours ago

    $170,000 - $260,000 (USD) per year *
    Description

    The Quality Engineer is responsible for ensuring that all products, processes, and systems comply with applicable global regulatory requirements and internal quality standards. This role supports manufacturing operations, leads quality investigations, drives continuous improvement, and serves as a subject matter expert in quality systems, validation, and risk management.

    REQUIRED SKILLS AND EXPERIENCE

    · A minimum of four (4) years of relevant professional work experience in the Medical Devices industry.

    · Strong knowledge of quality management systems and regulatory requirements (e.g., ISO 13485, FDA QSR).

    · Exceptional problem-solving and analytical skills, with the ability to identify root causes and implement effective solutions.

    · Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

    · Experience with CAPAs non-conformances, audits, and process validation.

    · Strong trending and data analysis skills.

    · Troubleshooting expertise.

    · Proven competence to evaluate, communicate, and act upon significant risks, demonstrating leadership of the high standards of quality and compliance.

    · Act with speed, flexibility, and accountability to achieve goals. Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results.

    * This salary range is an estimation made by beBee
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