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    Quality Engineer II - St Louis, United States - Stereotaxis

    Stereotaxis
    Stereotaxis St Louis, United States

    2 weeks ago

    Default job background
    Description
    Shift TypeJob TitleQuality Engineer IIEducationBachelor's DegreeLocationStereotaxis - St. Louis, MO 63101 US (Primary)

    Career LevelExperienced (Non-Manager)CategoryRegulatory and ComplianceDate Needed ByJob TypeFull-timeTravelJob DescriptionCompany Description:

    Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures.

    Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory.

    These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information.

    Core components of Stereotaxis' systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere.


    For more information, please visit Summary:
    The Quality Engineer II is responsible for ensuring compliance with the US and International Quality System requirements. Areas of focus are product development/design controls, process improvement, supplier quality, and failure investigation.


    Essential Responsibilities:

    • Act as Quality Engineering representative on development teams to ensure compliance with Regulations, International Standards, and internal design control system requirements.
    • Assist with complaint handling processes, nonconformance/deviation processes, and perform corrective and preventive action activities.
    • Support risk analysis activities (i.e., risk mgmt. planning, FMEAs, Hazard Analysis) as required to support product development activities.
    • Lead in the implementation of assurances, process controls, NCRs, and CAPA systems designed to meet or exceed internal and external requirements.
    • Perform DHR review/release of sterile and non-sterile products.
    • Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements
    • Evaluates mechanical product design and identifies potential design quality issues and drives technical decisions. Drives design quality, reliability, and compliance to standards and regulations.
    • Manages timelines for investigations to ensure that reporting is performed on time and investigations are addressed in a timely manner.
    • Work with process owners to create or update procedures to address quality risks.
    • Perform internal audits and lead on external audits as needed

    Job RequirementsQualifications & Skills:

    • B.S. Degree in a Science or Engineering field highly preferred and/ or business experience.
    • 2-4 years' experience in regulated medical device industry highly preferred.
    • Strong knowledge of global Quality System regulations related to design control, risk analysis, and GMPs.
    • Professional certification(s) relevant to the position preferred (e.g., CQA, CQM, and/or CQE).
    • Experience with electronic quality system documentation management.
    • Excellent written and verbal communication skills.
    • Legally authorized to work in the United States

    Work Conditions:
    This role is an in-office position at Stereotaxis' headquarters

    Culture:
    Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement.

    We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.

    Hiring ManagerExemption Type# of Hires Needed1Wage Amount
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