Qa Specialist

Radiometer

Bangalore, India
Base: as per india; bonus/equity: bonus/incentive ...
Design control activities
Iso 14971 risk management
Medical device testing iec 60601-1
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: bonus/incentive pay; Benefits: comprehensive, competitive benefit programs

Skills & Requirements

Must-have

  • design control activities
  • ISO 14971 risk management
  • medical device testing IEC 60601-1
  • global regulatory standards
  • process development and lean thinking

Nice-to-have

  • culture of belonging
  • continuous improvement
  • diverse ideas
  • collaborative spirit
  • mentoring junior QA members

Key Requirements

  • M.Tech /B.Tech/BE degree in engineering
  • 8–10 years of QA experience
  • design controls within regulated environments
  • FDA 21 CFR Part 820, ISO 13485, MDR, and IVDR knowledge
  • US, Europe, Canada, and Asia regulatory knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter