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    • CAPA Engineer - Apodaca - ICU Medical

    ICU Medical
    ICU Medical Apodaca

    hace 3 semanas

    Default job background
    Descripción

    Investigation Activities Coordinator Role

    The primary goal of this position is to plan, coordinate, and execute investigation activities from initiation until completion of the written exception report. This role is responsible for solving quality problems and investigations to identify the root cause of issues and implement effective solutions within the manufacturing process.

    Key Responsibilities:

    • Collaborate with investigation record owners to ensure thorough investigations are conducted.
    • Drive investigations to their root cause using a systemic approach and root cause analysis tools.
    • Assist with impact assessments and document investigation findings and corrective actions as necessary.
    • Contribute to writing investigation reports that comply with all regulatory requirements.
    • Plan, coordinate, and execute investigation activities from initiation until completion of the written exception report.
    • Capture and report on Quality System metrics.
    • Participate in Management Review process data collection.
    • Promote and participate in Quality Culture engagement activities.
    • This role ensures compliance of Company operations with applicable laws, regulations, standards, good business practices, and company documented procedures.
    • Engage others in promoting and participating in 5S initiatives to contribute to continuous site improvement.

    Education and Experience:

    • Bachelor's degree from an accredited college or university.
    • Three to five years of experience in a FDA-regulated company or similar environment with Quality System experience in GMP and ISO quality system standards.
    • CQE, Six Sigma Green Belt, Microsoft Office, AS400, SAP, Trackwise, Nonconformance tracker system desirable.
    • English fluency required.

    Key Skills and Abilities:

    • Strong leadership, collaboration, and stakeholder management skills.
    • Excellent verbal communication and technical writing abilities.
    • Ability to develop quality assurance plans, policies, and systems meeting standards and business requirements.
    • Good decision-making and problem-solving skills.

    Working Style and Decision Making:

    • The incumbent will have full responsibility for decisions within normal boundaries.
    • Decisions will align with business objectives, and technical decisions are generally made independently.
    • General guidance and direction will be provided by direct management, but the incumbent will operate independently most of the time.
    • This position has authority to request operations to implement immediate containment actions due to quality issues.

    ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

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