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Gondrecourt-le-Château

    Quality Engineer - St Paul, United States - Insight Global

    Insight Global
    Insight Global St Paul, United States

    2 weeks ago

    Insight Global background
    Description

    Your Responsibilities Will Include:

    Co-Ordinate project activities with teams, communicate progress, collaborate on key deliverable, and meet critical phase timelines.

    Providing continuous and rigorous assessment of Material Controls processes to ensure compliance with FDA regulations, ISO 13485, and Medical Device Requirements and applicable global regulations.

    Ownership of highly visible, global, systemic CAPAs.

    Determining and tracking actionable material controls metrics to improve supply chain effectiveness, product quality and patient outcomes.

    Support information gathering and preparation activities for applicable Global Quality System meetings and forums (e.g. audits, signals reviews)

    Facilitate change management with cross functional groups (Supplier Quality, Purchasing, Sourcing, IT and Analytic Teams).

    Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.

    Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.

    In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

    What Were Looking For In You:

    Required Qualifications

    Bachelor's degree in life science, Quality or Engineering field.

    Proven experience (2-4 years) in manufacturing, quality, IT or regulatory/compliance environment.

    Excellent verbal / written communication, interpersonal, project management, organizational and analytics skills.

    Experience working in an FDA and ISO 13485 environment and an understanding of quality system requirements as stated within 21 CFR Part 820 and ISO

    Must be proactive and be a contributing member of a highly visible team.

    Occasional travel may be required to support and facilitate workshops

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