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    Quality Engineer II - St Louis, United States - Stereotaxis

    Stereotaxis
    Stereotaxis St Louis, United States

    2 weeks ago

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    Description

    Quality Engineer II

    Company: Stereotaxis - St. Louis, MO

    Stereotaxis is the leading global firm in cutting-edge robotic technologies tailored to enhance arrhythmia treatment and endovascular procedures. Their mission is to innovate, develop, and provide robotic systems, instruments, and information solutions for interventional laboratories. These advancements aid physicians in delivering top-notch patient care with robotic precision and safety, enhancing lab efficiency, productivity, and seamless integration of procedural data. Key components of Stereotaxis' systems have obtained regulatory approval in various regions including the US, EU, China, Japan, and Canada.

    Position Summary:

    The Quality Engineer II ensures alignment with US and International Quality System requirements, focusing on product development/design controls, process enhancement, supplier quality, and failure investigation.

    Essential Responsibilities:

    • Act as the Quality Engineering representative on development teams to ensure adherence to Regulations, International Standards, and internal design control system requisites.
    • Assist in complaint processing, nonconformance/deviation handling, and execute corrective and preventive actions.
    • Support risk analysis initiatives including risk management planning, FMEAs, and Hazard Analysis to back product development endeavors.
    • Lead the deployment of assurances, process controls, NCRs, and CAPA systems to meet or surpass internal and external demands.
    • Carry out DHR review/release for sterile and non-sterile products.
    • Support site quality system operations to guarantee compliance with global Regulations and Standards such as 21 CFR 820, ISO 13485, EU MDR, and MDSAP.
    • Evaluate mechanical product design, identify potential design quality concerns, and steer technical verdicts.
    • Oversee investigation timelines to ensure timely reporting and resolution.
    • Collaborate with process owners to establish or revise procedures addressing quality risks.
    • Conduct internal audits and lead external audits when required.

    Qualifications & Skills:

    • B.S. Degree in a Science or Engineering field highly preferred or equivalent business experience.
    • 2-4 years' experience in the regulated medical device industry highly favored.
    • Robust knowledge of global Quality System regulations linked to design control, risk analysis, and GMPs.
    • Preferred professional certification(s) like CQA, CQM, and/or CQE.
    • Experience in managing electronic quality system documentation.
    • Exceptional written and verbal communication proficiencies.
    • Authorized to work in the United States.

    Work Conditions:

    This role is office-based at Stereotaxis' headquarters.

    Culture:

    At Stereotaxis, integrity, intellectual excellence, responsiveness, reliability, and a commitment to continuous enhancement are highly esteemed. We are proud of the positive influence of our labor and of fostering a collaborative, innovative environment that welcomes challenges.

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