Manager - Quality Engineer - Medical Device - Rosemont - Fusion Life Sciences Technologies LLC

    Fusion Life Sciences Technologies LLC
    Pharmaceutical / Bio-tech
    Description

    Job Title: Quality Engineer– Medical Devices

    Location : Rosemont, IL

    Duration: 6 Months Contract

    Job Summary:

    We are seeking an experienced Quality Engineer with a strong background in medical devices and machining operations. This role will lead quality system development, support design controls, manage risk activities, and ensure compliance with 21 CFR 820, ISO 13485, and EN standards. The candidate will also mentor teams and drive continuous improvement initiatives.

    Key Responsibilities:

    · Lead and continuously improve Quality Systems for R&D in compliance with 21 CFR 820, ISO 13485, and EN requirements.

    · Ensure robust implementation of Design Controls and maintain Design History Files (DHF).

    · Lead Risk Management activities (Risk Management Plans, FMEA, Risk Reports) for products under design authority.

    · Apply Six Sigma and statistical tools to support product development and process control.

    · Oversee machining-related quality processes, validation, and inspection controls.

    · Maintain quality metrics, reports, and management review data.

    · Mentor and provide technical direction to Quality Engineers and cross-functional teams.

    · Support audits, regulatory inspections, and continuous improvement initiatives.

    Qualifications:

    · Bachelor's degree in Engineering or related field.

    · 8+ years of experience in medical device quality engineering, including machining processes.

    · 3+ years of managerial or team leadership experience.

    · Strong knowledge of Design Control, Risk Management (ISO 14971), and DHF management.

    · Experience with statistical analysis and Six Sigma methodologies.


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