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Project Coordinator – Documentation
Raynham, MA, US
Engineering
High School or equivalent
Full Time, Temporary
40.00
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Raynham, MA, US
40.00
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Engineering
High School or equivalent
First Shift (Day)
Job details
At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. We’re hiring an IFU Project Coordinator for a long-term opportunity. With us, it’s all about finding the job that’s just right.
IFU Project Coordinator
(Instructions for Use Project Coordinator – Documentation)
Raynham, Massachusetts (preferably local/hybrid)
Pay starts: $40/hr W2 (DOE)
Enhanced Benefits: Paid vacation & holidays + Health benefits Medical, Dental & Vision
The IFU Coordinator is responsible for processing Instructions for Use (IFUs) for both Mitek and Spine operating companies. The IFU content document is provided to the IFU Coordinator, who then routes it for approval in the PLM Document Management System, sends it out for translation/layout, and to a supplier for printing. The individual coordinates these tasks both internally and with several external suppliers, holding suppliers accountable for delivery dates. The individual is required to visually proofread the IFUs prior to releasing the final artwork files to production print using Docuproof software for revisions. Coordination of the printer proof task with supply chain and production, both domestic and international, is extremely important. All activities should be performed ensuring compliance with defined procedures – attention to detail is a must.
The IFU Coordinator partners with project leaders to map out project timelines, monitor tasks to key milestones, and escalate to project management when due dates are at risk. An additional responsibility is to maintain a tracker to monitor all open IFU projects to ensure they are progressing according to set timelines. This individual must be comfortable working with minimal supervision while under tight timelines. Excellent organizational and communication skills are required as the role interfaces with multiple functions.
Tasks:
- Execute IFU changes within the PLM system
- Proofread redline IFUs to appropriate approved documentation
- Organize project work for execution
- Enter information and maintain status of updates to IFUs per applicable project plan
- Work with team to support IFU business activities
- Provide required documentation/reports
- Communicate escalation of issues and delayed activity to Project Manager
Required:
- Experience working in a regulated medical industry
- Proficient in Microsoft Office Suite of Applications
- 1-3 years professional experience with ability to prioritize work with limited supervision; comfortable working independently
- Experience working in a team environment
- Good communication and organizational skills
- Attention to detail
- Excellent organizational and communication skills are required
Preferred:
- Associate’s or bachelor’s degree preferred but not a requirement
- Experience with a PLM System
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