Senior Lead Specialist, Design Quality Engineer, Coils

Design Quality Engineer role leading compliance and quality initiatives for MR Coils technology across product development, manufacturing, and service phases. Responsible for ensuring adherence to FDA and ISO regulatory requirements while supporting new product introductions and audit readiness at the Aurora, Ohio facility.

Responsibilities

• Lead quality culture and compliance activities for MR Coil technologies across design, manufacturing, and service
• Ensure adherence to GE HealthCare Quality Management System and regulatory requirements including 21 CFR 820 and ISO 13485
• Manage CAPA projects with robust root cause investigations and nonconformance evaluations
• Support product launches including design and manufacturing transfer activities
• Represent organization to external regulatory agencies and maintain audit readiness

Requirements

• Bachelor's degree from accredited institution or high school diploma with 6+ years relevant experience
• Minimum 3 years Quality Assurance, Quality Engineering, or Design Controls in regulated medical device industry
• Demonstrated knowledge of FDA 21 CFR Part 820 and ISO 13485 standards
• Proficiency with quality and process improvement tools and methodologies
• U.S. work authorization; visa sponsorship not available
• Medical device NPI experience including Design Controls and Production Process Controls (desired)
• Strong critical thinking, root cause analysis, and cross-functional communication abilities (desired)