Senior Lead Specialist, Design Quality Engineer, Coils

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

Job Description Summary

Join our team as a Design Quality Engineer, where you will play a pivotal role in developing and implementing compliance strategies to bring MR Coils technology to market. You will lead compliance efforts for New Product Introductions (NPI) and Installed Base (IB) projects at our MR Coils site. Your responsibilities will span design and development, design transfer, manufacturing, and service.

Job Description Summary

Join our team as a Design Quality Engineer, where you will play a pivotal role in developing and implementing compliance strategies to bring MR Coils technology to market. You will lead compliance efforts for New Product Introductions (NPI) and Installed Base (IB) projects at our MR Coils site. Your responsibilities will span design and development, design transfer, manufacturing, and service.

As a key member of the NPI core team, you will ensure adherence to the GE HealthCare Quality Management System and applicable regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross‑functionally to enable robust quality decisions. In this role, you will have a direct impact on patient safety, audit readiness, and the commercial delivery of GE HealthCare MR Coils.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world‑changing realities, and join an organization where every voice makes a difference—and every difference builds a healthier world.

Job Description

Roles and 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.

Required 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.

Desired Characteristics

• Experience in New Product Introduction of medical devices, including Design Controls, Production and Process Controls, and Installation and Servicing.
• Experience applying the GE HealthCare Quality Management System in NPI programs.
• Strong technical aptitude.
• Influencing skills and the ability to clearly communicate requirements related to Design Controls, Design Verification and Validation, Production and Process Controls, Corrective and Preventive Action (CAPA), and Risk Management across functions.
• Demonstrated ability to collaborate effectively and resolve conflicts.
• Strong critical thinking, problem‑solving, root cause analysis, and process improvement skills.
• Excellent interpersonal and leadership abilities.
• Proven ability to manage multiple priorities effectively.

We expect all employees to live and breathe our behaviors: act with humility and build trust, lead with transparency, deliver with focus, and drive ownership—always with unyielding integrity.

Our total rewards are designed to unlock your ambition by providing the support and flexibility needed to turn ideas into world‑changing realities. Our salary and benefits reflect the strength and scale of our global organization, and you will be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.

Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No