Regulatory Engineering Change Control Specialist at Impact Business Group Inc

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Engineering Change Control Specialist for a 12 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

This function will be directly supporting our clients EUMDR project on Site.

Position Description (Principle Duties and Responsibilities)

• Periodically work independently with vendors.
• 2D drawing & GD&T knowledge or experience.
• Create and manage Engineering Change Requests as well as product impact assessments.
• Manage Engineering Change Notices for process changes from creation to final approval
• Demonstrate a general understanding of Product Part Approval Process (PPAP)
• Demonstrate a general understanding of First Article Inspection (FAI) process
• Periodically lead projects and processes; work with cross-functional teams to get these projects completed. Ability to multi-task between different projects and changes.
• Investigate Quality issues for root cause and recommend/implement corrective actions.
• Ability to oversee team members workload and provide support when issues arise.
•  Work to support team members as both mentor/mentee when necessary.

Requirements:

• Bachelor's Degree in Engineering or relevant field of study Qualifications and Work Experience Required
• 1-3 years' experience in a production/manufacturing environment.
• Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, Project, etc), and experienced work in a Quality Management System and UDI/MDD/MDR/UKCA Regulatory Compliance project experience is preferred.
• Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at team level meetings and lead meetings as necessary.
• Demonstrate strong teamwork and time management skills as well as be able to operate in a fast-paced environment.
• Ability to perform in and be challenged by a multi-disciplinary team-based environment, which places a high degree of emphasis on accountability for quality/GMP/GDP compliance.
• Provide technical support for quality control, process improvement, equipment qualifications, and process validations.
• Operate within our clients quality management system (QMS) to produce and/or review documentation such as, inspection guide sheets, product drawings, dynamic control plans (DCPs), and standard operating procedures (SOPs)