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    Sr Quality Systems Specialist - St Paul, United States - Three Point Solutions

    Three Point Solutions
    Three Point Solutions St Paul, United States

    2 weeks ago

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    Description
    Job Description

    Job Description

    Job Title - Sr Quality Systems Specialist

    Exempt
    Number of Positions

    1
    Job Location

    • Mounds View, Minnesota Can work remotely
    Job Start Date

    • 5/1/24
    Job End Date

    • 10/31/24

    Must Have:
    Minimum Requirements

    Bachelor's degree with 4+ years of work experience in Quality, Manufacturing, or regulated industry OR Advanced degree with 2 years of work experience in Quality or regulated industry
    Experience in a regulated environment
    Experience working with audit findings, corrections, and corrective actions
    Experience in medical device, pharmaceutical and/or a comparable regulated environment
    Influence management skills; ability to work constructively across all functions of the organization as well as external customers
    Project management skills
    Quality System documentation systems (e.g. Agile) and Audit documentation systems experience (e.g. Trackwise)
    Experience reviewing technical documentation
    Strong written and verbal communication skills
    Ability to educate people in Quality Systems and the Audit program
    Experience with quality tools and process improvement techniques
    Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
    Strong analytical and decision-making skills

    Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements in general and specific to CAPA.

    Travel 10% domestic and internationally
    #ZR
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