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 for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D. This position is part of the QA Design Control team, located at BDC (Bengaluru Development Center) Bangalore. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
This position reports to the Senior Manager QA and is part of the QA Design Control team located at BDC (Bengaluru Development Center) Bangalore and will be an on-site role. You will be a part of the QA Design Control team for supporting design control activities by working collaboratively with our QA colleagues from across the globe on products related to Immunoassays, Blood Gas, Transcutaneous monitoring and IT System solutions. If you thrive in a multifunctional and an amazing role and want to work to build a world-class Quality Assurance organization—read on
In this role, you will have the opportunity to:
Design Control & Product Development:
+ Lead QA Activities: Drive quality assurance in design and development projects, including outsourced design, ensuring compliance with FDA, ISO, and global regulatory requirements.
+ Provide Expert Guidance: Advise on design control elements such as risk management (ISO 14971), usability engineering, requirement traceability, cybersecurity, and software lifecycle processes (IEC 62304).
+ Review and Approve Documentation: Evaluate and approve design documentation, verification and validation protocols, and reports to ensure regulatory compliance.
+ Facilitate Risk Management: Conduct risk assessments and maintain risk management files throughout the product lifecycle.
+ Support Design Transfer & Post-Market: Ensure smooth design transfer and post-market activities, driving continuous compliance and improvement.
+ Collaborate & Mentor: Work closely with R&D, external partners, Supplier Quality, Operations, and RA; mentor junior QA team members and contribute to quality training programs.
+ Ensure Audit Readiness & Continuous Improvement: Maintain up-to-date knowledge of standards and regulations, ensure QA system updates, support internal/external audits, drive BDC-specific quality initiatives, and demonstrate Danaher values using DBS tools.
The essential requirements of the job include:
The ideal candidate should hold a M.Tech /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.
+ Experience: 5–7 years in Quality Assurance within Healthcare/Medical Devices, with proven expertise in design control processes and regulated environments (FDA 21 CFR 820, ISO 13485, MDR, IVDR).
+ Technical Expertise: Hands-on experience in risk management (ISO 14971), usability, requirement management, systems engineering, cybersecurity, validation/verification, and IEC 62304 compliance.
+ Domain Knowledge: Strong understanding of immunoassay principles and product lifecycle for immunoassay devices (hardware and software), including analytical performance verification.
+ Process & Standards: Familiarity with global regulatory standards across major markets, system integration testing, and lean process development.
+ Leadership & Mentorship: Ability to mentor junior QA team members and contribute to quality training programs
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 .
