Senior Change Analyst

WerfenOrangeburg, NY
$100,000 - $120,000Remote

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position Summary: Responsible for facilitating and coordinating Change Orders meetings. Determines how to improve and maintain the Change Control System and associated processes. Acts as the primary interface between engineering, manufacturing, field service, marketing, etc. to ensure the appropriate changes are properly documented and implemented.

Requirements

  • Bachelor's Degree or equivalent.
  • Minimum of 5 years of specific experience.
  • Proven background with electronic change control systems and their interface with ERP systems
  • 10 years of related experience in Operations, Quality, or R&D areas.

Responsibilities

  • Facilitates and assist with Change Order creation, planning and implementation.
  • Tracks and coordinate Change Order development, approval, and implementation.
  • Provides expert assistance with technical aspects of Change Orders, including material disposition, field proliferation and implementation of follow-up actions required.
  • Ensures that existing Change Order procedures and Documentation Standards are followed and adhered to.
  • Checks Change Orders for Completeness, Accuracy and Consistency.
  • Interfaces with and assists all other departments involved in Change Order process as required.
  • Assists Change Control Board with Review and Checking of Change Orders to support their approval of Change Orders.
  • Creates and maintains Change Order metrics focused on cycle time reduction process enhancement.
  • Creates of reporting mechanisms derived from electronic systems interaction related to Change Control functions.
  • Administrative duties related to systems and employee coordination in the Configuration Management arena.
  • All other duties as assigned by manager
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