QA Specialist

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.\n\nLearn about the Danaher Business System which makes everything possible.\n\nThe QA Specialist 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 (Bangalore Development Center) Bangalore. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.\n\nThis position reports to the Director QA and is part of the QA Design Control team located at BDC (Bangalore 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\n\nIn this role, you will have the opportunity to:\nDesign Control & Product Development:\nLead QA activities for design and development projects, especially with Outsourced Design Partners, ensuring compliance with FDA, ISO, and global regulatory requirements.\nProvide expertise in design controls, including ISO 14971 risk management, usability engineering, requirements traceability, and medical device testing (IEC 60601-1).\nReview and approve key design documentation, including V&V protocols/reports, and facilitate risk assessments and maintenance of risk management files.\nDrive cross‑functional collaboration with internal and external R&D teams, Supplier Quality, Operations, and RA to ensure robust design transfer, post‑market compliance, and audit readiness.\nSupport quality excellence initiatives, mentor junior QA members, maintain up‑to‑date regulatory knowledge, and apply DBS tools to strengthen the BDC quality system.\nThe essential requirements of the job include:\nThe 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.\n8–10 years of QA experience in the healthcare/medical device/IVD domain, specializing in design controls within regulated environments.\nExpertise in risk management (ISO 14971), usability, requirements management, systems engineering, cybersecurity, and V&V, with working knowledge of IEC 60601‑1.\nStrong understanding of global regulatory standards including FDA 21 CFR Part 820, ISO 13485, MDR, and IVDR across USA, Europe, Canada, and Asia.\nSkilled in process development and lean thinking, with experience mentoring junior QA members and contributing to quality training programs.\n\nJoin 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.\n\nFor more information, visit www.danaher.com .\n]]>