• Supplier Quality Specialist

    BioFire Diagnostics, LLC. (Salt Lake City, UT)


    Position Summary & Responsibilities:

    The Supplier Quality Specialist ensures that products and materials from suppliers meet the company’s quality standards for the Salt Lake City Site. This role involves evaluating supplier performance and supporting supplier quality improvement initiatives. The Specialist collaborates with internal team members and suppliers to resolve quality issues and enhance processes while maintaining compliance with industry standards and regulations. Strong analytical skills and effective communication are essential for success in this position.

     

    + Perform all work in compliance with the Company’s Quality Management System.

    + Lead the Materials Review Board (MRB) for Instruments and Reagents to monitor supplier performance and facilitate continuous improvement opportunities.

    + Lead and coordinate with subject matter experts on Supplier Corrective Action Requests (SCARs).

    + Collect, analyze, and prepare supplier performance data for Instrument, Reagent, and Indirect suppliers.

    + Follow the Change Control procedures and address supplier notifications for Instrument, Reagent, and Indirect suppliers.

    + Maintain the management of the Critical Parts List.

    + Support the development of the annual Supplier Audit Schedule.

    + Participate in regulatory audits (BSI; FDA; IVDR; MDSAP; etc.) by addressing supplier quality related topics.

    + Support the Purchasing Department in the following activities: Supplier Selection; Supplier Documentation; the Approved Supplier List; Supplier Performance; and the Supplier Watchlist.

    + Support continuous improvement plans requiring supplier quality input.

    + Provide supplier quality performance reports (score cards) for the Site.

    + Contribute to the execution of supplier quality agreements in accordance with procedural requirements.

    + Alert suppliers of supplier-cause non-conformances.

    + Improve, enhance, and keep the Supplier Quality program in compliance with FDA and ISO 13485 standards as directed and aided by direct Manager.

    + Perform other duties as assigned.

    Education, Skills, & Experience:

    + Bachelor’s degree with 3+ years of experience in Supplier Quality Management or a similar role (ex. Quality Assurance, Quality Engineering. Supplier Management, etc)

    + High School Diploma/GED with 7+ years of experience in Supplier Quality Management or a similar role also accepted

    + Strong analytic and problem-solving skills.

    + Excellent communication and interpersonal skills.

    + Knowledge of quality standards and regulations. (e.g., ISO, Six Sigma).

    + Excellent reading, writing, and communication skills.

    + Attention to detail.

    + Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, CoPilot, etc.)

    + Experience with business analysis software such as Tableau is a plus.

    + Self-motivated and able to manage time effectively.

    + Critical and strategic thinker.

    + Desire to work hard and learn; humility; strong work ethic; coachable; team player; and strive for excellence.

     

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