Senior Design Quality Engineer & NPI Lead

GE HealthCare; Aurora (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

GE HealthCare is seeking a Design Quality Engineer to lead compliance strategies for MR Coils, guiding NPI and Installed Base projects from design through service. This role directly impacts patient safety and regulatory readiness.

You will collaborate across functions to uphold 21 CFR 820, ISO 13485, and MDSAP, apply Lean methods, and support product launches while ensuring quality decisions and robust CAPA investigations.

Qualifications

• Bachelor’s degree from an accredited university or college or a high school diploma with at least 6 years of relevant work experience.
• Minimum of 3 years of quality assurance, quality engineering, or design controls experience in a regulated industry; medical device experience preferred.
• Strong understanding of medical device QMS and regulatory requirements (FDA 21 CFR Part 820, ISO 13485).
• Knowledge of quality improvement tools and methodologies.
• Legal authorization to work in the United States (visa sponsorship not available).

Responsibilities

• Lead quality and compliance activities for MR Coil technologies across design, development, transfer, manufacturing and service.
• Ensure adherence to GE HealthCare QMS and regulatory requirements (21 CFR 820, ISO 13485, MDSAP) while driving process effectiveness.
• Ensure plans, protocols, results and conclusions are developed, reviewed and approved per procedures.
• Represent GE HealthCare to external regulatory agencies and drive audit readiness.
• Perform internal audits to ensure quality standards and regulatory compliance.
• Ensure CAPA projects have robust root cause analyses and nonconformance evaluations.
• Support successful product launches including design and manufacturing transfers.
• Apply Lean methodologies to solve problems and improve processes.
• Support analysis to achieve quality objectives and priorities.

Skills

Quality Assurance

Quality Engineering

Design Controls

Regulatory Knowledge

Process Improvement

Education

Bachelor’s degree or 6+ years experience

Job description

GE HealthCare is seeking a Design Quality Engineer to lead compliance strategies for MR Coils, guiding NPI and Installed Base projects from design through service. This role directly impacts patient safety and regulatory readiness.

You will collaborate across functions to uphold 21 CFR 820, ISO 13485, and MDSAP, apply Lean methods, and support product launches while ensuring quality decisions and robust CAPA investigations.