• Supplier Quality Engineering Manager

    Posting Date 2 months ago(6/14/2018 7:37 AM)
    Requisition ID
    2018-4736
    Job Location(s)
    Bloomington IN United States
    Travel
    20-30%
    Shift Type
    First
    Position Type
    Full Time
    Company
    Cook Inc.
    Category
    Quality
  • Overview

    The Supplier Quality Engineering Manager serves on a cross functional team, ensuring the adequacy, suitability and compliance of the Quality Management System processes within Supplier Control. Manages day-to-day quality operations and provides leadership and direction to the supplier quality team. 

    Responsibilities

    • Oversees the quality activities related to selecting, developing and maintaining suppliers including:

    • Approve quality documents, analyze improvement of the QMS and other department processes, including reviewing, updating, creating, and implementing SOP’s to support improved processes and compliance

    • Responsible for ensuring that processes needed for the quality management system are documented; reporting to top management on the effectiveness of the process(es) and the need for improvement; promoting the awareness of applicable regulatory and quality management system requirements throughout the organization

    • Responsible for driving quality globally and ensuring suppliers are meeting the quality standards

    • Review, approve, monitor and reporting on quality agreements and changes with suppliers and quality of supplier records to drive supplier quality management

    • Provide quality expertise and leadership to management and operational personnel

    • Prepare, communicate and monitor quality plans and metrics to support operations

    • Adhere to the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements, driving quality throughout the organization

    • Attend, present and provide data for meetings to include project updates and reviews

    • Participate in hiring, interviewing and onboarding process of new hires

    • Responsible for performance management and annual reviews of direct reports

    • Authorization of weekly time sheets, concur, PTO request, department specific documents

    • Foster and maintain a workplace culture respectful and supportive of individual differences
    • Must work and interact effectively and professionally with and for others throughout various levels of the global organization

    • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal
    supervision

     

    Qualifications

    • Bachelor's degree in Engineering or Life Science

    • Minimum 3 years experience working with quality management system

    • Minimum of 5 years experience in a regulated industry, preferably in a medical manufacturing environment

    • Supplier, Contract, and Quality Agreement experience highly preferred

    • Previous leadership experience, 5 years preferred

    • Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Business Objects

     

      

    Physical Requirements:

    • Works under general office environment conditions

    • Utilizes close visual acuity for working with computers and equipment

    • Frequently required to stand, walk, and hear

    • Occasionally required to lift up to 20 pounds.

    • Travel 20-30% (domestic and internationally)

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