AddressGE 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.
Essential Responsibilities
Responsible for the Quality Management System and Compliance activities for the site
Drives process efficiency
Utilizes professional experience to provide Compliance guidance to colleagues and assist with problem resolution
Applies technical writing skill to maintain Quality procedures
Represents GE Healthcare to external agencies
Creates a Quality culture and drives Quality metrics
Qualifications/Requirements
Bachelor's Degree or a minimum of 4 years' work experience
Minimum of 1 year experience working in a regulated industry
Ability to communicate effectively in English (both written and oral)
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications
Desired Characteristics
Minimum of 3 years' experience in a regulated industry is preferred
Demonstrated understanding or aptitude to understand ISO 13485 Medical Device QMS requirements and regulatory requirements
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of QMS processes like Document controls, Corrective & Preventive Action (CAPA), complaints & risk management & product quality improvement
Demonstrated collaboration, negotiation & conflict resolution skills
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment
Demonstrated understanding of continuous quality / process improvement tools: (As defined by the site, e.g. DMIAC, SPC, Lean SS, 5S)
Experience leading and implementing change
Experience performing internal audits and participating in external audits
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task & handle tasks with competing priorities effectively
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators
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.
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.
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