Project Coordinator - Monroeville, PA

Monroeville, Pennsylvania, United States


Project Coordinator

Monroeville, PA

Full Time Position

Job Description:

Project Lead for specific types of engineering changes that do not require a Technical Lead or project manager.

• Lead the coordination and implementation of change notice packages within FDA, TUV ISO 9000 regulations, working to maintain proper configuration management principles

• Successfully Coordinate/Communicate cross-functional engineering change activities (to multiple facilities as necessary) in order to meet agreed upon deadlines by working with multiple departments including: Quality, Regulatory, Tech Writing, V&V, Operations, Distribution, Service, Marketing, Customer Service, etc.

• Proactively identify project risks and assist in resolution of roadblocks preventing timely release of change notices.

• Create and/or advise on the development/maintenance of Bills of Materials as needed to support changes.

• Execute tasks to complete changes that might also include facilitation of first article approvals, tracking actions to completion.

• Excellent attention to detail, time management, and communication skills.

• Ability to understand and follow process requirements.

• Proficient with Microsoft Office (Word, Excel, Visio, Project, etc).

• 3+ years’ experience in a medical device (or other regulated) industry.

• High school diploma required, bachelor’s degree preferred.

• Experience with SAP enterprise change management tools desirable.



Apply for this job