GE HealthCare is a leading global medical technology and digital solutions innovator committed to creating a world where healthcare has no limits
Job Summary
GE HealthCare is a leading global medical technology and digital solutions innovator committed to creating a world where healthcare has no limits.
The role involves driving compliance activities, ensuring quality and regulatory compliance, and partnering with cross-functional teams to support quality deliverables and audit readiness.
GE Healthcare offers a culture that fosters care, collaboration, and support, with total rewards designed to unlock ambition and provide career opportunities.
Matching Summary
GE HealthCare is a leading global medical technology and digital solutions innovator committed to creating a world where healthcare has no limits.
Skills & Requirements
Must-have
Quality management system oversight
Design controls expertise
Regulatory compliance management
Risk management and mitigation
Cross-functional team collaboration
Audit readiness and support
Quality metrics and reporting
Nice-to-have
Leadership and negotiation skills
Customer centric mindset
Problem-solving techniques
Matrix organization experience
Inclusion and diversity focus
Key Requirements
Bachelor’s degree in Engineering
Minimum 10 years quality assurance experience
Experience in healthcare industry
Specialist in design controls and risk management
Knowledge of ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971, EU MDR, IMDR
Experience with packaging specifications and validation protocols
Experience with QMS and compliance for NPI/programs
Experience with ISO/MDSAP audits and FDA inspections