QA Specialist I
Radiometer
- Salary
- ₹20 - 30 LPA
- Experience
- 8+ yrs
- Location
- Bangalore, Karnataka, India
- Job type
- Full-time
Required skills
- risk management
- usability engineering
- requirement traceability
- medical device testing
About the role
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 on
In this role, you will have the opportunity to:
Design Control & Product Development:
Lead QA activities in design and development projects with a focus on Outsourced Design, ensuring compliance with FDA, ISO, and other global regulatory requirements.
Provide expert guidance on design control elements including risk management (ISO 14971), usability engineering, requirement traceability, medical device testing (IEC 60601-1)
Review and approve design documentation, verification and validation protocols, and reports.
Participate in supplier audit at Outsourced Design Partners
Facilitate risk assessments and contribute to risk management files.
Support design transfer and post-market activities ensuring continuous compliance and improvement.
Collaborating closely with R&D, external R&D partners, Supplier Quality, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities.
Mentor junior QA team members and contribute to quality training programs.
Keep up to date knowledge of standards, regulatory requirements and regulations applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
Ensure that the projects and teams at BDC are Audit ready and provide support during the Internal and External audits of BDC
Provide support in driving BDC specific Quality initiatives
Demonstrate Danaher values and adopt DBS tools
About Radiometer
At Radiometer, one of Danaher's 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.
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