ECI · 1 week ago
Senior Quality Engineer - Technical Transfer - Medical Devices #0572 Taunton, MA
Taunton, MA
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expECI is a global leader in professional consulting services for the life sciences industry, known for providing transformative solutions. The Senior Quality Engineer will support cross-functional teams in transferring equipment for medical device production, ensuring compliance with regulatory requirements and quality standards while driving continuous improvement in processes.
BiotechnologyConsultingLife ScienceProject Management
No H1B
U.S. Citizen Only
Responsibilities
Support process validation, equipment qualification, and documentation transfer
Product technical guidance on equipment validation strategies
Drive continuous improvement in transfer processes to ensure timely completion of deliverables and ensure product quality
Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards
Ensure products and processes meet specific standards
Provide Support for testing, analysis, and continuous improvement
Support updates to ECI’s client processes or other documentation as directed
Drive completion of Quality activities within prescribed timelines
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
8+ years of experience in medical device manufacturing, product development, or technology transfer
Proven track record supporting complex, multi-site projects
Strong knowledge of design control, process validation, and manufacturing scale-up
Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution
Exceptional communication, collaboration, and problem-solving skills
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase