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ECI · 1 week ago

Senior Quality Engineer - Technical Transfer - Medical Devices #0571 Springfield, MA

Springfield, MA

Full-time

Hybrid

Senior Level, Lead/Staff

8+ years exp

ECI is a global leader of professional consulting services for the life sciences industry, seeking a Senior Quality Engineer to support cross-functional teams in transferring equipment used in the production of medical devices. The role involves ensuring compliance with regulatory requirements, quality standards, and business objectives while driving continuous improvement in transfer processes.

BiotechnologyConsultingLife ScienceProject Management

Growth Opportunities

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

Process validationEquipment qualificationRegulatory complianceDesign controlManufacturing scale-upCommunication skillsCollaboration skillsProblem-solving skills