Radiometer, a Danaher operating company, seeks a QA Professional to ensure product safety, reliability, and regulatory compliance during development and maintenance of diagnostic devices. The role involves leading design control activities, risk management, and cross-functional collaboration within the India Development Center in Bangalore.
Responsibilities
Drive QA activities in design and development projects, ensuring FDA, ISO, and global regulatory compliance
Advise on design control elements including risk management, usability, and software lifecycle processes
Evaluate and approve design documentation, verification/validation protocols, and regulatory reports
Conduct risk assessments and maintain risk management files throughout product lifecycle
Collaborate with R&D, suppliers, operations, and external partners; mentor QA team members
Requirements
https://jobeax.com/link/s1WvHFV9ITSwCkyS, https://jobeax.com/link/2DENLGgQM7whDhaE, or BE degree in engineering or relevant university-level qualification
5–7 years QA experience in healthcare/medical devices sector
Expertise in design control, FDA 21 CFR 820, ISO 13485, MDR, and IVDR regulations
Hands-on knowledge of ISO 14971 risk management, IEC 62304, and usability engineering
Strong understanding of immunoassay device principles and product lifecycle
Familiarity with global regulatory standards and system integration testing
Ability to mentor junior team members and contribute to training programs
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