Job Description Summary
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements that support the GEHC Quality Management System including validation compliance activities for non-product computer system validation (CSV).
Ensures that projects and products are capable and will meet specified standards (Preventive). Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services.
Ensures deployed procedures and processes are operationalized to employees across IT, Manufacturing, Service, Operations, and Quality / Regulatory functions.
Stays informed of industry trends that may influence work.
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
Drives and is accountable for operational excellence of assigned program(s), with duties including project reviews, feasibility analysis, cost benefit analysis, prioritization, resourcing, initiation, execution and closure for all project work related to the program
Clearly communicates program status, issues, risks, plans, etc. to senior management
Manages budgets and contracts associated with program(s) or initiative(s) as applicable
Manages activities of project team resources to support and deliver solutions relating to the program(s) , including the development of internal and external communications, establishing roadmaps and benchmarks, requirements gathering, development, implementation, testing and training plans, and ensuring the successful transition to the functional owners
Maintains effective working relationships with peers and vendors to seamlessly integrate the program area into the overall strategic objectives and activities of the organization
Coordinates program and validation support activities, including education and training cross-functional teams to ensure adoption of best practices, continuous improvement processes and standardized work through the Quality System
Provides on-site implementation, validation, and audit support
Assist teams in identifying and remediating compliance risks. Support planning and execution of risk retirement actions
Bachelor’s degree in engineering or technical discipline plus 4 years working experience within healthcare regulations.
Understanding of product development, IT systems, manufacturing, quality control and servicing in a medical device environment.
Demonstrated program / project management experience in a global environment, including project initiation, scoping, resourcing, scheduling, budgeting, requirements gathering, risk management, and communication
Demonstrated experience in Quality Systems, Process Validation, and Computer System Validation
Process improvement experience, knowledge of continuous improvement methodologies & in-depth understanding of related processes
Masters degree in engineering or other technical discipline
Demonstrated experience with regulations in the medical device and / or pharmaceutical industries (e.g. FDA CFR 58, 211, 820, 600 and EU GMPs)
Experience with USP, EP, ICH Standards, PDA / ISPE guidance, and ISO certifications
Demonstrated knowledge of Quality Management System tools
Demonstrated ability to excel in a global matrix organization
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.
Relocation Assistance Provided : No