GE HealthCare Program Manager Quality Ultrasound Digital 

Remote, Remote 

116959728

The Program Manager, Quality, Ultrasound Digital role will be responsible for driving the GE HealthCare Quality Management System integration to ensure harmonization and optimization for the newly acquired Intelligent Ultrasound Ltd business. This will include ensuring alignment of procedures to assure product safety, quality, and site compliance by driving business alignment to industry requirements. The role will also continue to support the products included in the integration long-term.
Responsibilities

• In partnership with the GE HealthCare and Intelligent Ultrasound Ltd leadership team, responsible for creation and execution of the GE Healthcare Quality Management System (QMS) integration plan to ensure harmonization and optimization for the Intelligent Ultrasound Ltd products to assure product quality and safety.

• Ensure quality and regulatory compliance while driving process effectiveness and efficiency.

• May represent GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.

• Identifies critical path decisions, makes recommendations, and influences / gets buy-in from segment leadership and business process owners to maximize QMS integration, compliance and effectiveness.

• Owns all project risk; including time and scope, and the associated plans to contain and/or mitigate risk.

• Coordinates Operational Reviews working across the organization to ensure targeted outcomes are achieved.

• Leads alignment of Intelligent Ultrasound Ltd quality metrics to GEHC.

• Supports external and internal audit activity as needed.

• Supports ongoing product development and relevant QMS activities in support of the integrated Intelligent Ultrasound Ltd products.

Qualifications

• Bachelor's Degree in a scientific discipline; and significant working experience in the medical device industry and/or regulated industry.

• Demonstrated understanding or aptitude in Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Skills

• Masters Degree in Science or Business Administration.

• Experience working with SW Medical Devices.
  Experience working and communicating directly with external medical device regulators.

• Experience in developing, implementing and maintaining quality system processes and driving improvements to processes.

• Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills.

Total Rewards

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.