QA Professional in Bangalore, भारत

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