Lead Design Quality Engineer, MR Coils & NPI

GE HealthCare; South Dakota; On-site; USD 90,000 - 120,000; Full time

Job summary

GE HealthCare in the United States seeks a Design Quality Engineer to lead compliance strategies for MR Coils, guiding NPI and Installed Base projects across design, transfer, manufacturing, and service.

You will ensure adherence to 21 CFR 820, ISO 13485, and MDSAP within GE HealthCare's Quality Management System, using problem-solving and Lean approaches to deliver safe, effective medical devices.

Qualifications

• Bachelor’s degree from an accredited university or college OR a high school diploma/GED with at least 6 years of relevant work experience.
• Minimum of 3 years of relevant experience in Quality Assurance, Quality Engineering, or Design Controls within a regulated industry; medical device experience preferred.
• Demonstrated understanding of medical device Quality Management System and regulatory requirements, including but not limited to FDA 21 CFR Part 820 and ISO 13485.
• Demonstrated knowledge of quality and process improvement tools.
• Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, is not available for this position.

Responsibilities

• Foster a Quality culture by leading quality and compliance activities for innovative, leading‑edge MR Coil technologies across design and development, design transfer, manufacturing, and service.
• Ensure adherence to the GE HealthCare Quality Management System and regulatory requirements (e.g., 21 CFR 820, ISO 13485, MDSAP) while driving process effectiveness and efficiency.
• Ensure plans, protocols, results, and conclusions are developed, reviewed, and approved in accordance with applicable procedures.
• Represent GE HealthCare to external regulatory agencies and drive audit readiness.
• Perform internal audits to ensure quality standards and regulatory requirements are met.
• Ensure the quality of CAPA (Corrective and Preventive Action) projects, including robust root cause investigations and nonconformance evaluations.
• Support successful product launches, including design and manufacturing transfers.
• Apply Lean methodologies to solve problems, improve daily work, and simplify processes.
• Support analysis and execution to achieve quality objectives and priorities.

Skills

Quality Assurance

Quality Engineering

Design Controls

FDA 21 CFR 820

ISO 13485

MDSAP

CAPA

Root Cause Analysis

Risk Management

New Product Introduction

Lean Methodologies

Education

Bachelor’s degree or higher

HS diploma + 6 years experience

Job description

GE HealthCare in the United States seeks a Design Quality Engineer to lead compliance strategies for MR Coils, guiding NPI and Installed Base projects across design, transfer, manufacturing, and service.

You will ensure adherence to 21 CFR 820, ISO 13485, and MDSAP within GE HealthCare's Quality Management System, using problem-solving and Lean approaches to deliver safe, effective medical devices.