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 <a href="https://danaher.com/our-businesses" target="_blank">Danaher’s</a> 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 <a href="https://www.danaher.com/how-we-work/danaher-business-system" target="_blank">Danaher Business System</a> which makes everything possible.The 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.This 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 onIn this role, you will have the opportunity to:Design Control & Product Development:<ul><li>Lead QA activities for design and development projects, especially with Outsourced Design Partners, ensuring compliance with FDA, ISO, and global regulatory requirements.</li><li>Provide expertise in design controls, including ISO 14971 risk management, usability engineering, requirements traceability, and medical device testing (IEC 60601-1).</li><li>Review and approve key design documentation, including V&V protocols/reports, and facilitate risk assessments and maintenance of risk management files.</li><li>Drive 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.</li><li>Support quality excellence initiatives, mentor junior QA members, maintain up‑to‑date regulatory knowledge, and apply DBS tools to strengthen the BDC quality system.</li></ul>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.<ul><li>8–10 years of QA experience in the healthcare/medical device/IVD domain, specializing in design controls within regulated environments.</li><li>Expertise in risk management (ISO 14971), usability, requirements management, systems engineering, cybersecurity, and V&V, with working knowledge of IEC 60601‑1.</li><li>Strong understanding of global regulatory standards including FDA 21 CFR Part 820, ISO 13485, MDR, and IVDR across USA, Europe, Canada, and Asia.</li><li>Skilled in process development and lean thinking, with experience mentoring junior QA members and contributing to quality training programs.</li></ul>Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at <a href="https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home" target="_blank">Danaher Benefits Info</a>.The annual salary range for this role is as per India. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.This job is also eligible for bonus/incentive pay.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 <a href="http://www.danaher.com/" target="_blank">www.danaher.com</a>.

QA Specialist

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Danaher

Pipeline