Job Information
GE Healthcare Sr Lead Specialist Quality - Healthcare Quality in Bengaluru, India
Job Description Summary
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.
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.
Job Description
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.
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.
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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Additional Information
Relocation Assistance Provided: No