Qa Specialist

Radiometer

Bangalore, India
Base: as per india; bonus/equity: eligible for bon...
Design control
Risk management iso 14971
Usability engineering
The QA Specialist is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D

Job Summary

  • The QA Specialist is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D.
  • Lead QA activities for design and development projects, especially with Outsourced Design Partners, ensuring compliance with FDA, ISO, and global regulatory requirements.
  • Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The QA Specialist is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D.

Salary

Base: As per India; Bonus/Equity: eligible for bonus/incentive pay; Benefits: comprehensive, competitive benefit programs

Skills & Requirements

Must-have

  • Design Control
  • Risk Management ISO 14971
  • Usability Engineering
  • Requirements Traceability
  • Medical Device Testing IEC 60601-1
  • FDA 21 CFR Part 820
  • ISO 13485
  • MDR
  • IVDR

Nice-to-have

  • Continuous Improvement
  • Culture of Belonging
  • Diverse Ideas
  • Cross-functional Collaboration
  • Lean Thinking

Key Requirements

  • 8-10 years QA experience
  • M.Tech /B.Tech/BE degree in engineering
  • Global regulatory standards knowledge
  • Process development skills

Work Rights

Not specified

Tailored Resume

Cover Letter