• RF Certification Coordinator & Documentation…

    BioFire Diagnostics, LLC. (Hazelwood, MO)


    POSITION SUMMARY

    + Coordinate Radio Frequency certifications and their renewal with UL Solutions for DENSICHEK products for various countries.

    + Work with Regulatory and countries around the globe that have different processes to determine when an RF certificate is deemed valid. Radio Frequency (RF) certifications require coordination with UL-contracted parties to maintain compliance and certification status. Calendar maintenance for timely results.

    + Create a photo-driven marketing supplement identifying DENSICHEK components with current labeling containing electrical symbols, global country RFID symbology, logos, etc.

    + Responsible for development, support, and change control of assembly procedures and related documentation for instrument products, devices, and/or spare parts manufactured at bioMérieux, St. Louis.

    + Creates, edits, and distributes various documentation in support of manufacturing processes

    PRIMARY DUTIES

    + Participate in / conduct bi-monthly meetings with UL regarding countries impacted by Radio Frequency and the tasks unique to each country. Maintain the online Repository once UL notifies bioMerieux of Certificate approval.

    + Manage bi-monthly meetings with local marketing, regulatory, and project management for RF. This may include of sales volume impacted and the operating budget RF certifications per calendar year.

    + Manage departmental Change Request workflows in TrackWise Digital in order to support Instrument Engineering projects and/or changes. Communicate with internal review teams to obtain approvals necessary for product/procedure release as defined by Company procedures and the FDA Quality Systems Regulations.

    + Research, write, modify, and format assembly documentation consisting of hardware assembly and test methods according to departmental styles and standards. Proofread documentation for accuracy and adherence to standards

    + Consolidate and reconcile all comments and inputs from production personnel, Engineering, or others and incorporating these inputs into the appropriate documentation

    KNOWLEDGE, EXPERIENCE & SKILLS

    + Technical High School Diploma and 4 years of industrial medical experience, technical publications experience and/or experience in a regulated environment

     

    An Associate’s Degree and 2 years of industrial medical experience, technical publications experience and/or experience in a regulated environment

     

    A Bachelor’s Degree in Graphic Arts, English or Technical Communication with 0 years of experience

    + Experience with Adobe InDesign, Illustrator, and Photoshop strongly preferred.

    + Proficiency in Microsoft Office Suite is required.

    + Experience with SolidWorks Composer a plus

     

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