Website Radiometer

The essential requirements of the job include:

The ideal candidate should hold a M.Tech /MCA/B.Tech/BE degree in engineering, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted.

  • 8 to 10 years of proven experience as a quality assurance professional in a Healthcare domain
  • Specialist in design control processes in one or more of the following areas: Risk Management, Usability, Requirement management, systems engineering and architecture, Cybersecurity, Validation and verification
  • QA Design Control experience from the medical device or IVD industry or other similar regulated industries specifically in medical device software
  • In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA 21 CFR Part 820, ISO 13485, IVDR and MDR, IEC 60601-1/2)
  • Must have knowledge and experience in working with ISO 14971 and IEC 62304
  • Knowledge & experience on Agile/ Scrum SW development methodologies
  • Process development and lean thinking.
  • Structured person with skills for planning and visual management.

It would be a plus if you also possess previous experience in:

  • Metrics planning, implementation and reporting

Hybrid Job Posting Language:

At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes

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