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Cedar Rapids

    Director of Quality Manufacturing - Cedar City, United States - ALIGN PRECISION

    ALIGN PRECISION
    ALIGN PRECISION Cedar City, United States

    3 weeks ago

    ALIGN PRECISION background
    Description

    Job Description

    Summary

    The Director of Quality Assurance is responsible for establishing and overseeing robust quality processes to ensure that manufactured products meet customer specifications, including FDA, ISO 13485 and AS compliance. This role involves developing a competent quality assurance team to drive company objectives.

    Primary Duties

    • Oversee FDA 21 CFR 820, ISO 13485, and AS certifications as a management representative
    • Develop, implement, and maintain Quality System processes in compliance with FDA regulations and ISO standards
    • Establish a supportive work environment that aligns with the company's Quality Policy and Objectives
    • Recruit, train, and manage quality control and assurance staff including inspection personnel
    • Lead initiatives for continuous improvement such as lean and Six Sigma
    • Monitor and report internal and external quality metrics
    • Participate in strategic planning and foster a safety-oriented culture

    Required Education and Experience

    • Bachelor's degree in Quality, Engineering, or related field
    • Minimum 10 years of experience in manufacturing with 5 years in leadership roles
    • Excellent communication and organizational skills
    • Demonstrated leadership qualities with a focus on continuous improvement
    • Knowledge of FDA regulations, ISO standards, and experience with QMS/ERP systems

    Necessary Skills, Abilities and Knowledge

    • Thorough understanding of Quality principles, methodologies, and tools
    • Proficiency in Microsoft Office applications and ERP systems
    • Effective communication skills across all business levels
    • Ability to lead organizational change and develop personnel
    • Strong analytical, decision-making, and problem-solving skills
    • Financial Management and Business Acumen

    Additional Notes

    ALIGN PRECISION advocates for workplace diversity and is an Equal Opportunity Employer. All positions at ALIGN PRECISION are at-will.

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