Program Manager, Quality, Ultrasound Digital

Job Description Summary

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.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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.

Responsibilities

Job Description

• 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.
  
  

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

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.

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.

Additional Information

Relocation Assistance Provided: No