Senior Lead Specialist, Design Quality Engineer, Coils

Job Description SummaryJoin 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 play a pivotal role in leading compliance of New Product Introductions (NPI) and Installed Base (IB) projects at our MR Coils site. Your responsibilities will span across 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 regulatory requirements, including 21 CFR 820, ISO 13485, and MDSAP. By employing strong critical thinking and influencing skills, you will work cross-functionally to ensure robust quality decisions. In this role, you will have a direct impact on ensuring 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

• Fosters a Quality culture by leading quality and compliance activities for innovative, leading-edge MR Coil technologies within the areas of design and development, design transfer, manufacturing, and service.
• Ensures adherence to GE HealthCare QMS and regulatory requirements (e.g. 21 CFR 820, ISO 13485, MDSAP) while driving process effectiveness and efficiency. Ensures plans, protocols, results, and conclusions are generated, reviewed, and approved according to applicable procedures.
• Represents GE HealthCare to external regulatory agencies and drives audit readiness.
• Performs internal audits to ensure quality standards and regulatory requirements are addressed.
• Ensures quality of CAPA (Corrective and Preventive Action) projects, including robust root cause investigations, and nonconformance evaluations.
• Support successful product launch of 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)
• At least 3 years of relevant experience in Quality Assurance, Quality Engineering or Design Controls in a regulated industry, Medical Device experience preferred
• Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements including but not limited to FDA CFR 21 820 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, for this job opening is not available.

Desired Characteristics

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

We expect all employees to live and breathe our behaviors: to 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 giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

Additional Information

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.