GE HealthCare Sr Associate Specialist CAPA - Healthcare Quality 

India, Karnataka 

105449111

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). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations.

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.

• Develop and Implement requirements from established CAPA process for modalities at site.

• 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.

• Monitor the CAPA metrics and represent in CAPA review board for assigned modalities at site.

• Identify preventive actions and drive site continual improvement projects.

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 3 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 CAPA and Design controls.

Inclusion and Diversity

Ourare 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.