QA Professional

Job Summary

The QA Professional, QMS Digitalization is responsible for supporting development and lifecycle management of digital tools, computerized systems and AI-enabled applications used within the Regulatory Affairs and Quality Assurance (RAQA) organization. QA Professional, QMS Digitalization partners in RAQA digitalization initiatives and collaborates closely with process owners to design, validate, maintain, and continuously improve digital tools, computerized systems and AI-enabled applications that support quality and regulatory operations.

This position reports to the Director, Global QMS and is part of the Global QMS Compliance team. Position will be located in India and will be an on-site role.

Responsibilities

• Lead and support the development, configuration, and deployment of in-house IT tools, automated workflows, reports, dashboards, and AI-enabled solutions supporting 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.

Requirements

• Bachelors or Masters degree in Information Technology, Computer Science, Engineering, Life Sciences, Quality Management, or a related discipline.
• Minimum 3 years of experience in supporting development, qualification, validation, and maintenance of digital tools and AI solutions
• Professional experience in working within medical industry and knowledge of medical device standards and regulatory requirements (such as ISO 13485, IVDR, MDR, and FDA regulations).
• Strong analytical and problem-solving skills and ability to balance compliance requirements with business needs and innovation
• Excellent communication skills in English

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.