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Project Coordinator

Location:Morrisville, NC
Benefits:Comprehensive Benefits Package including 401(k)
Employment Type:Full Time
Description:The Project Coordinator is responsible for managing Design History File documentation and ensuring compliance with regulatory requirements as well as the Company’s Quality Management System procedures. The position’s primary responsibility is ensuring compliance to the Company’s Design Control and Change Control procedures.
Duties:• Create and maintain Design History files from product conception through obsolescence
• Ensure that master drawing files and Design History files are accurate and current, and that effective control is maintained for product documentation
• Coordinate the Change Control Board (CCB), process changes through the Change Control Process and monitor implementation plans related to the changes
• Verify integrity/accuracy of data input into Agile/Unipoint and ensure that all documentation meets established quality standards
• Communicate project action items to the team and work with team members to drive action item closure
• Report status and open items to executive management
• Support FDA or other regulatory audits
• Coach and teach the Design Control and Change Control Processes to all team members
• All other essential duties as directed
Qualifications:EDUCATION & EXPERIENCE

• Bachelor’s degree required (preferably in an engineering or scientific discipline)
• Solid working knowledge of Design and Change Control processes in a regulated environment (preferably medical devices)
• Detail-oriented and meticulously organized approach to simple and complex tasks
• Ability to prioritize tasks, think critically, solve problems and exceed expectations within a fast-paced and deadline-driven environment
• Strong written and verbal communication skills
• 3-5 years minimum experience in a Project Coordination or related role

KNOWLEDGE, SKILLS & ABILITIES

Strong proficiency with Microsoft Excel, Word and Outlook
Strong proficiency with Enterprise Quality Management Software such as Agile, SAP, TrackWise, Unipoint or equivalent
Basic proficiency with Microsoft Project
Basic proficiency with Material Requirements Planning (MRP) systems such as Syspro, SAP, Servigistics or equivalent


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