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Change Specialist I

Plymouth, MN 55442

Posted: 02/09/2024 Employment Type: Contract Job Category: Engineering Job Number: 600078 Is job remote?: No Country: United States

Job Description


Target PR Range: 18-24/hr
*Depending on experience 

Job Summary: 
The Change Specialist I is responsible for analyzing and processing Change Order Quality Checks and implementation of Change Orders in the designated PLM and ERP system.  This includes communication with Change Managers on issues identified and provide feedback on how to correct them.  The Change Specialist I review Quality Checks and implement Pre-Release and Post-Release tasks and enters information into the PLM and ERP system in relationship to the releases of the Change Orders for use within the organization.  The Change Specialist I is also responsible to completing Documentation Services activities and providing Change Control support.

Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform but are not limited to.
1.    Perform and take on the responsibility of the Change Specialist role.
2.    Main focus is analyzing and processing Quality Check and implementation of Change Orders within the PLM and ERP systems.
3.    Prioritize workload and obtains priorities from Supervisor and completes changes submitted from across the Electrophysiology organization.
4.    Provides support and feedback to Change Managers if issues were identified.
5.    Interacts with Change Managers to explain PLM and ERP system functionality and workflow.
6.    Manages ERP Product Configuration
a.    Change Master
b.    Material Master/Material Extension
c.    BOM
d.    Routers
e.    Inspection Plan
7.    Complete Documentation Services activities (including but not limited to):
a.    BOM Import
b.    Change Activity Assignee Task
c.    Legacy Load
d.    Issuing, managing, and receiving Laboratory Notebook
e.    Create, managing, and update Distribution Book
f.    Attach Proxy and Regulatory Affair Change Assessment
Equipment: List the type of equipment the incumbent will utilize in this position. 
Works with standard office equipment such as telephone, cellular phone, fax/copier, and a personal computer with standard office software.  

Working Conditions: Describe the work environment characteristics representative of those encountered by an employee performing the essential functions of this job.
Works primarily in a standard office environment with air conditioning, good lighting with a low to moderate noise level. May travel between company facilities, visit labs, and other areas as necessary.
Overtime may be required based on business needs.

General Qualifications

•    HS Graduate or Equivalent. 
•    0 – 2 years of experience in a Document/Engineering Change Control role, preferably in a regulated industry. 
•    Requires basic Microsoft Office skills.
•    Able to enter data in PLM and ERP system provided per Change Orders. 
•    Must have strong interpersonal skills.
•    Able to contribute to a department problem-solving team.
•    Ability to work in a geographically diverse business environment.
•    Ability to work within a team and as an individual contributor in a fast-paced, changing environment. 
•    Strong verbal and written communications with ability to effectively communicate with Change Managers and other Documentation Services staff in the organization.
•    Multitasks, prioritizes, and meets deadlines in timely manner.
•    Strong organizational and follow-through skills, as well as attention to detail. 
•    Ability to maintain regular and predictable attendance.
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