• Quality Specialist

    Posting Date 1 month ago(1 month ago)
    Requisition ID
    2018-4952
    Job Location(s)
    West Lafayette IN United States
    Travel
    Less than 10%
    Position Type
    Full Time
    Company
    Cook Research Inc.
    Category
    Quality
  • Overview

     Cook Research Incorporated is currently accepting applications for a Quality Specialist to become a part of our growing Quality team.

    Responsibilities

    • Ensure that the quality policy and quality system are maintained and implemented at all levels of the organization

    • Review and approve protocols, reports, project documentation, validation documentation, and regulatory submissions for accuracy and compliance to applicable procedural standards and Standard Operating Procedures

    • Ensure Quality Management Systems (QMS) procedures are compliant with regulations and standards

    • Assess impact of proposed procedural changes

    • Perform project inspection

    • Train staff on QMS processes

    • Report quality issues to management

    Qualifications

    • Bachelor’s degree in Engineering, Physical or Life Science field, or closely-related technical field and one (1) year of experience in a regulatory environment within the medical, bio-technical, or pharmaceutical industry.

    • Employer will also accept a Master's degree in Engineering, Physical or Life Science field, or closely-related technical field in lieu of the Bachelor's degree and one (1) year of experience requirements.

    • Education and/or experience must include: ISO 13485; ISO 17025; Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards; auditing; and MS Office Software (Word, Excel, Visio, PowerPoint, Project)

    • Must have current authorization to be employed in the U.S. without employer sponsorship

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