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    Quality Engineer - Baltimore, United States - Galen Robotics

    Galen Robotics
    Galen Robotics Baltimore, United States

    1 week ago

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    Description


    The Quality Engineer will focus on developing, implementing, and performing Quality Assurance and Quality Control related activities to support the products designed and manufactured by Galen Robotics.


    Key Activities:
    Assist in the continuous evaluation and improvement of the Galen Quality System.

    Serve as an independent reviewer for design reviews.

    Perform supplier evaluation related activities.

    Develop metrics to evaluate supplier performance and perform supplier performance evaluations.

    Maintain and update Supplier Performance Files.

    Develop and execute incoming raw material inspection activities.

    Develop and execute in-process manufacturing quality inspection activities.

    Participate in Risk Management, Design Verification, Transfer and Change activities.


    Education:
    Bachelor's Degree in engineering or scientific discipline.

    Experience:

    3 years of medical device, pharmaceutical or other regulated industry (e.g., automotive, nuclear, telecom, defense, etc.) experience.


    2 years of quality assurance and/or quality control experience in a regulated industry (e.g., medical device, pharmaceutical development, automotive, etc.).


    Additional Desired Skills/Qualifications/Competencies:
    Medical Device product design experience

    ASQ CQE/CSQE/CQA Certification

    ISO 13485:2016 Auditor or Lead Auditor Certification

    Lean and/or 6-Sigma training or certification


    Physical Requirements:
    Must be able to lift 30 lbs.

    Ability to sit at a desk and/or stand at a manufacturing location for extended periods of time.


    NOTE:
    Reasonable accommodations may be made to enable individuals with disabilities to perform this task.

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