Senior Lead Specialist, Design Quality Engineer, Coils

MS0062 USA Instruments, Inc; South Dakota; On-site; USD 95,000 - 130,000; Full time

Job summary

GE HealthCare is seeking a Design Quality Engineer to lead quality and regulatory activities for MR Coil projects. You will drive compliance with QMS and standards such as 21CFR820 and ISO13485 across design, transfer, manufacturing, and service while ensuring audit readiness and patient safety.

You will collaborate cross-functionally to enable robust quality decisions, employing CAPA, lean methods, and risk management to support successful product introductions and ongoing quality improvements.

Qualifications

• Bachelor’s degree or 6+ years of relevant experience in QA/Design Controls in a regulated industry.
• 3+ years in Quality Assurance/Quality Engineering in medical devices.
• Knowledge of FDA 21CFR Part 820 and ISO13485.
• Experience with CAPA and root cause investigations.
• Authorized to work in the U.S.; visa sponsorship not available.

Responsibilities

• Lead quality and compliance activities across design, development, transfer, manufacturing, and service for MR Coil technologies.
• Ensure adherence to GE HealthCare QMS and regulatory requirements (21CFR820, ISO13485, MDSAP) while improving processes.
• Represent GE HealthCare to regulatory agencies and drive audit readiness.
• Perform internal audits and oversee CAPA, root cause analyses, and nonconformances.
• Support product launches and design/manufacturing transfers; apply Lean to improve efficiency.

Skills

Quality culture

Regulatory knowledge

CAPA investigations

Design Controls

Lean methodologies

Education

Bachelor's degree

High school diploma + 6 years exp

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. 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 21CFR820, ISO13485, 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.

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., 21CFR820, ISO13485, 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 21CFRPart820 and ISO13485.
• 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.

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 At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.