Quality Specialist – Change Coordinator
Location: Indianapolis, IN
Pay Rate: $ 28.00 - $43.00 Based on Education and experience.
Facilitates and manages requested product and process changes through the PLM and MDG-M systems. Demonstrates an advanced knowledge of these systems and is able to apply this expertise to look in-depth at information pertaining to change management, document control, and materials management. Independently interprets change request submissions of all complexity and executes the changes in the appropriate system. Works with customers to identify their needs and ensures that a complete and accurate change request is submitted. Tracks and follows the workflow to ensure timely results that achieve stated objectives. Duties are varied, involving research, analysis, and solution development and deployment. Evaluate and escalate issues when necessary. Departmental representative or participant on assigned project teams. Manages assigned projects to completion by due date. Assists lower level staff by providing guidance, advice, and training.
KEY ROLES & RESPONSIBILITIES (required):
-Responsible for the management and processes of the PLM and MDG-M systems. Monitors progress of workflows, helps facilitate issues during the workflow, and escalates as needed. Assumes the role of a Change Coordinator or Content Manager as needed.
-Prepares and/or revises departmental procedures within PLM Engineering scope.
-Participates on cross-functional project teams to provide documentation and distribution expertise. Also provides appropriate support to help transfer new products into production.
-Collaborates on complex changes and provides guidance and understanding to users to process changes through the system quickly and efficiently.
-Reviews and ensures that change requests and change notices move through the system accurately and efficiently.
-Acts as liaison between departments and quality assurance, quality systems, etc.
-Supports Process Leads on internal project work.
-Exercises good time management and project management skills
-Works with the Global PLM team to ensure system accuracy and completeness of change management, document control, and materials management.
-Participates on and leads special projects as assigned.
-Supports LCM activities/changes throughout the product lifecycle.
-Distributes documentation and software to internal customers, vendors, affiliates, and manufacturing partners.
KNOWLEDGE/ SKILLS/ATTRIBUTES (optional): The minimum education, knowledge, experience, skills, and attributes required to perform the essential functions of the job.
-High school diploma.
-3 years’ related experience.
-Strong communication, influence, leadership, conflict management, negotiation, and writing skills.
-Proficiency with office software.
-Strong communication, customer service, and interpersonal skills.
-Ability to work independently, multi-task, and adjust rapidly to new priorities.
-Excellent organizational, time management and analytical skills.
-Demonstrated competency in taking initiative.
-Ability to handle multiple functions at one time.
Additional preferred requirements (optional):
-Previous experience in a regulated industry preferred.
-Windchill and SAP experience preferred.
-Good understanding of the regulations that govern the medical device industry and the policies needed for effective change control.
-Solid understanding of manufacturing and inventory management procedures.
Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.