QA Professional

Bring more to life.

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

AtRadiometerone ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers 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. Were a team that celebrates diverse ideas and continuous improvement. Here youll 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 theDanaher Business Systemwhich makes everything possible.

TheQA Professional QMS Digitalization is responsibleforsupporting 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 positionreports to theDirector Global QMSandis part of theGlobal QMS Compliance team. Position will be located inIndia and willbeanon-siterole.

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:

• 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

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

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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