• Quality Data Analyst

    Posting Date 5 months ago(3/19/2018 11:34 PM)
    Requisition ID
    2017-3629
    Job Location(s)
    Bloomington IN United States
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Quality
  • Overview

     The Quality Data  Analyst is responsible for working with subject matter experts, process owners, subsystem leaders, management with executive responsibilities and IT in helping to execute quality system planning, processes, verification, analysis and reporting methods while promoting a collaborative atmosphere of quality awareness and continuous improvement.

     

    Responsibilities

     Position will focus on application of process control methodologies and statistical analysis of quality data with ability to support any of the following responsibilities:
    • Enforce compliance through documented analysis of quality system and regulatory requirements
    • Organize internal completion of external quality questionnaires, SCARs and change notifications
    • Plan, document and participate in external audits performed by third parties, such as regulatory authorities
    • Compile, analyze and distribute reports regarding compliance, quality measures and business metrics
    • Support quality planning preparation, tracking and execution
    • Ensure that issues requiring action are identified, action is verified for implementation and effectiveness, and fed to CAPA system, as appropriate

    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization
    • Must maintain company quality and quantity standards
    • Ability to work in collaborative and independent work situations and environments with minimal supervision
    • Ability to remain calm and receptive in fast paced situations
    • Must be detail oriented with organizational and problem solving skills
    • Must have excellent analytical skills

     

     

    Qualifications

     • Bachelors degree or equivalent in a technical discipline or experience of such kind and amount as to provide a comparable background
    • Knowledge of medical device regulations, including pertinent standards and guidances, preferred or demonstrated regulatory knowledge in similarly regulated industry
    • Project management experience preferred

     • Knowledge of Cook Inc. quality system, associated documentation, and 

    product lines preferred or demonstrated medical device (or similar industry) quality system knowledge
    • Experience in statistical and analytical reasoning
    • Computer literacy and proficiency
    • Data analysis software experience required (e.g., Minitab, JMP, etc.)

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