Radiometer seeks a QA Professional to support digitalization of quality and regulatory systems. The role involves developing and validating digital tools, automated workflows, and AI-enabled applications that enhance RAQA operations within a medical device company.
Responsibilities
Lead development, configuration, and deployment of IT tools, automated workflows, dashboards, and AI solutions for RAQA
Partner with process owners to identify digitalization, automation, and AI governance opportunities
Plan, coordinate, execute, and document validation activities for computerized systems and digital tools
Serve as subject matter expert for digital solutions, systems validation, and AI governance in RAQA
Provide guidance to process owners on digital solution implementation and best practices
Requirements
Bachelor's or Master's degree in IT, Computer Science, Engineering, Life Sciences, or Quality Management
Minimum 3 years experience supporting development and validation of digital tools and AI solutions
Professional medical industry background with knowledge of ISO 13485, IVDR, MDR, and FDA regulations
Strong analytical and problem-solving capabilities balancing compliance with innovation
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