Senior Lead Specialist, Design Quality Engineer, Coils
GE HealthCare UK
Not specified; not specified; competitive compensa...
Not specified
21 cfr part 820 compliance
Iso 13485 regulatory requirements
Mdsap audit readiness
GE HealthCare is seeking a Senior Lead Specialist, Design Quality Engineer for MR Coils technology, focusing on compliance strategies and quality management. The role requires significant experience in quality assurance within a regulated industry, emphasizing collaboration and problem-solving skills
Job Summary
This role plays a pivotal part in developing compliance strategies to bring MR Coils technology to market while ensuring patient safety.
The successful candidate will lead quality and compliance activities across design, manufacturing, and service phases within the GE HealthCare Quality Management System.
Employees are expected to embody core behaviors including humility, transparency, focus, ownership, and unyielding integrity.
Matching Summary
Match Score: 85
GE HealthCare is seeking a Senior Lead Specialist, Design Quality Engineer for MR Coils technology, focusing on compliance strategies and quality management. The role requires significant experience in quality assurance within a regulated industry, emphasizing collaboration and problem-solving skills.
Salary
Not specified; Not specified; Competitive compensation and benefits package
Skills & Requirements
Must-have
21 CFR Part 820 compliance
ISO 13485 regulatory requirements
MDSAP audit readiness
CAPA root cause analysis
New Product Introduction support
Nice-to-have
Lean methodology application
Cross-functional influencing skills
Strong critical thinking abilities
Conflict resolution capabilities
MR Coil technology experience
Key Requirements
Bachelor's degree or 6 years relevant experience
Minimum 3 years in Quality Assurance or Design Controls
Legal authorization to work in the United States required