QA Professional

Danaher Corporation; Bengaluru; On-site; INR 1,500,000 - 2,600,000; Full time

Job summary

Radiometer, a Danaher operating company, seeks a QA Professional, QMS Digitalization to support development, qualification, and lifecycle management of digital tools, AI-enabled applications used within RAQA. Located in India, this on-site role partners with RAQA to drive digitalization initiatives.

You will plan, validate, and document computerized systems; act as SME for digital solutions and AI governance; and guide process owners in RAQA to balance compliance with innovation.

Qualifications

• Bachelor's or Master's degree in IT/CS/Engineering/Life Sciences/Quality Management.
• Minimum 3 years supporting development, qualification, validation of digital tools and AI solutions.
• Experience in medical industry and knowledge of ISO 13485, IVDR, MDR, and FDA regulations.
• Strong analytical, problem-solving, and English communication skills.

Responsibilities

• Lead and support development, configuration, 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 digitalization, automation, and responsible AI governance.
• 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.

Skills

Analytical skills

Problem solving

English communication

Education

Bachelor’s or Master’s degree in IT/CS/Engineering/Life Sciences/Quality Management

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Radiometer, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

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.

In this role, you will have the opportunity to:

• 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.

The essential requirements of the job include:

• Bachelor’s or Master’s 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

Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .