Project Coordinator - Documentation

IFU Project Coordinator

Kelly Science, Engineering, Technology & Telecom (SETT) is hiring an IFU Project Coordinator for a long-term opportunity in Raynham, MA. Pay starts: $40 - $43/hr (+/- 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

Preferred:

• Associate's or bachelor's degree preferred but not a requirement
• Experience with a PLM System

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.