GE HealthCare Manager NPI Quality Coils Site 

United States, Michigan 

780874698

As a NPI Quality Manager, MR Coils, you will develop and implement 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.

• Creates 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 compliance 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.
• Partners with top leadership to enable product development, including presenting solutions, program status, and risks.
• 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 high-risk CAPA (Corrective and Preventive Action) projects, including robust root cause investigations, and nonconformance evaluations.
• Apply Lean methodologies to solve problems, improve daily work, and simplify processes.
• Coaches and develops others with less experience.
• Communicates difficult concepts clearly and with consideration for other perspectives.
• May lead small projects with moderate risks and resource requirements.

Required Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 10 years of relevant work experience)
• At least 7 years of relevant experience in Quality Assurance or Design Controls in a regulated industry, either Medical Devices or Pharmaceuticals
• Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• 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 Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering or Manufacturing Engineering in the Medical Device field.
• Demonstrated expertise 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 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.
• Capability to lead, develop, communicate, and implement compliance strategies during crises.
• Exceptional critical thinking, problem solving, root-cause analysis, and process improvement skills.
• Excellent interpersonal and leadership abilities.
• Proficiency in Project Management and managing multiple priorities effectively.