• Manager, Senior Quality Systems

    Posting Date 2 months ago(11/12/2018 10:46 AM)
    Requisition ID
    2018-5636
    Job Location(s)
    Bloomington IN United States
    Travel
    10-20%
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Quality
  • Overview

    The Senior Manager, Quality Systems manages day-to-day operations of the Quality Systems team including other managers; provides directives to the entire department and serves as a subject matter expert for quality systems processes. 

    Responsibilities

    • Providing strategy for quality system compliance, initiatives, and improvements
    • Working with subject matter experts, process owners, subsystem leaders, MER and IT in helping to establish and maintain assessment and reporting methodology for quality system data at all levels: process, key process, subsystem, and quality management system.
    • Serving as site Management Representative - hosting 3rd party audits, identifying appropriate quality data, providing independent review of quality system performance at all levels and reporting any issues.
    • Responsible for the quality system processes and resource management for Management Review, Risk Management, CAPA, Internal Auditing, Statistics, and Data Analysis
    • Helping to ensure that issues requiring improvement are identified and fed to CAPA appropriately
    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization
    • Maintain regular and punctual attendance
    • Must maintain company quality and quantity standards
    • Must have effective oral and written communication skills
    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
    • Ability to remain calm and receptive in fast paced situations
    • Excellent organizational skills
    • Must be detail oriented
    • Maintain accurate and timely reports and records
    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
      - Must strictly adhere to safety requirements.
      - Maintain regular and punctual attendance.
      - Must maintain company quality and quantity standards.
      - Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
      minimal supervision.
      - Ability to remain calm and receptive in fast paced situations.

    Qualifications

    Minimum Work Experience/Educational Requirements:

    • Bachelors degree in a technical discipline; Master's degree preferred
    • 10+ years experience in quality systems
    • 5+ years experience in FDA-regulated industry
    • 3+ years management experience
    • Knowledge of medical device regulations, pertinent standards and guidances
    • Knowledge of quality tools & principles
    • Proven written and verbal communication skills
    • Basic knowledge of statistics
    • Proven problem solving skills 

     

    Physical Requirements/Work Environment:

    • Works under general office environmental conditions
    • Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
    • Some travel involved

     

    Other Requirements:

    Employee signs a non-competition and confidentiality agreements in relation to his/her employment with Cook. Employee acts in compliance with company policies including but not limited to, the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, Product Complaints, Privacy regulations and Cook Policy & Guidance On Interaction with Healthcare Professionals.

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