GE HealthCare Lead Quality Specialist 

United States, New York, City of Troy 

800530438

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the business.

Roles and Responsibilities

• Responsible for the Quality Management System and Compliance activities for the site
• Creates a Quality culture by driving compliance activities and Quality metrics
• Ensures quality and regulatory compliance while driving process effectiveness and efficiency
• Utilize proven interpersonal skills to communicate with direct colleagues and the business. Provides informal guidance to team members. Concisely explains complex information to others.
• Operates with some autonomy, activities require professional judgment
• Utilizes professional experience, technical skills, and analytical thinking to provide compliance guidance to colleagues and assist with problem resolution. May use multiple internal sources outside of own team to arrive at decisions.
• Applies technical writing skill to maintain Quality procedures
• Represents GE HealthCare to external agencies

Required Qualifications

• Bachelor's Degree or a minimum of 4 years' work experience in Quality management
• 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
• Experience performing internal audits and participating in external audits
• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
• Demonstrated collaboration, negotiation & conflict resolution skills
• Exceptional analytical, problem solving & root-cause analysis skills
• Experience leading and implementing change
• 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
• 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
• Strong oral and written communication skills. Ability to document, plan, market, and execute programs. Established project management skills.
• 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

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.