GE HealthCare Sr Lead Specialist Quality - Healthcare 

India, Karnataka 

81422779

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 (Preventive). Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents 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.

• Work with site teams to implement QMS and Regulatory requirements for Modality NPI and IB programs.

• Resolves issues using established procedures and collaborate with site teams to drive Corrective and preventive actions .

• Collaborates with Cross functional teams in problem solving through structured and technical approach.

Required Qualifications

• This role requires working experience in the Quality Management System in Healthcare Industry

• Bachelor's degree from an accredited university or college with at least 8 years of experience in Quality assurance or Regulatory affairs in healthcare industry

Desired Characteristics

• Knowledge of iSO13485 and regulatory standards FDA 21 CFR, EU MDR applicable for medical device industry

• Work experience in Quality Management system including Design controls and SDLC domain.

total rewardsare 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