Roles and Responsibilities

• Foster a Quality culture by leading quality and compliance activities for innovative leadingedge 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

• Bachelors 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 problemsolving 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 ownershipalways with unyielding integrity.

Our total rewards are designed to unlock your ambition by providing the support and flexibility needed to turn ideas into worldchanging 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.