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    Product Surveillance Analyst - Minneapolis, United States - The Fountain Group

    The Fountain Group
    The Fountain Group Minneapolis, United States

    1 month ago

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    Description

    Currently I have an opening for a Product Surveillance Analyst located in Plymouth, MN. Details for the position are as follows:
    Job Description:

    • Supporting complaint handling investigations, medical device reporting, or product analysis.
    • May perform multiple functions within the post-market surveillance department.
    • Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality.
    • Complete FDA MDR and other outside competent authority regulatory reports.
    • MS Office + OneNote + Team uses ETQ Reliance for complaints management - complaints come in from Sales/Field Reps, Clinical Engineers, anyone that works with our products can submit a complaint thru our FDA, but most of our complaints are from the staff that submits into ETQ.
    • Position is 70/30 - desk/laboratory position. Will work within complaint documentation and general laboratory testing of the products such as visual inspections, functional testing, etc.
    • Bachelors graduate within the life sciences or engineering - experience within pharmaceutical or medical device is preferred, hiring 3 people so also open to recent graduates looking to get their foot in the door
    Technical Information:
    • Pay: $23-25 hourly, depending on experience level (Hiring 3 people)
    • Onsite, M-F, 8am-5pm
    • 12-month contract with potential for extension or conversion to permanent
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