QA Professional

Overview

QA Professional (QMS Digitalization) responsible for supporting development and lifecycle management of digital tools, computerized systems, and AI-enabled applications used within the RAQA (Regulatory Affairs and Quality Assurance) organization.

What you'll do

• Lead and support development, configuration, and deployment of in-house IT tools, automated workflows, reports, dashboards, and AI-enabled solutions for RAQA processes.
• Partner with process owners to identify opportunities for process digitalization, automation, and responsible use of artificial intelligence.
• Plan, coordinate, execute, and document qualification and validation activities for computerized systems, digital tools, and AI-enabled applications.
• Act as a subject matter expert for digital solutions, computerized systems validation, and AI governance within RAQA.
• Provide guidance to process owners within RAQA.

What you'll need

• 3+ years of experience supporting development, qualification, validation, and maintenance of digital tools and AI solutions.
• Bachelor's or Master's degree in IT, Computer Science, Engineering, Life Sciences, Quality Management, or a related discipline.
• Medical industry professional experience and knowledge of medical device standards and regulatory requirements (ISO 13485, IVDR, MDR, FDA regulations).
• Strong analytical and problem-solving skills with ability to balance compliance requirements with business needs and innovation.
• Excellent communication skills in English.

Details

• Location: Bangalore, Karnataka, India.
• On-site role located in India.