Quality Systems Manager/Compliance - Mansfield, United States - Oxenham Group

    Oxenham Group
    Oxenham Group Mansfield, United States

    Found in: Lensa US 4 C2 - 1 week ago

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    Description

    Position:
    Quality Systems Manager


    Location:
    Onsite in Mansfield, MA

    Responsibilities

    Oversee compliance and the quality system including doc control, complaints, CAPA, NCMR, internal audit etc.
    Establish and manage Quality Compliance Budget

    Drives the development and improvement of new processes, implementation of standards, and Quality Plans in support of the organization's Quality strategies.

    Manage Doc Control and Quality Records processes and personnel
    Lead external regulatory body audits and inspections
    Manage Quality Management Review

    Qualifications

    Bachelor's degree in STEM
    5-7 years of experience as a manager in the Medical Device Industry.
    Strong knowledge of FDA regulations
    Experience in the front room of Audits

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