QA Professional
Danaher
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
- M.Tech, B.Tech, 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
Vacancy posted 1 day ago
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