Qa Professional I

Radiometer

Bangalore, India
Design control processes
Iso 13485
Fda 21 cfr 820
The QA Professional 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 Professional is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D.
  • You will be a part of the QA Design Control team for supporting design control activities by working collaboratively with our QA colleagues from across the globe on products related to Immunoassays, Blood Gas, Transcutaneous monitoring and IT System solutions.
  • Ensure Audit Readiness & Continuous Improvement: Maintain up-to-date knowledge of standards and regulations, ensure QA system updates, support internal/external audits, drive BDC-specific quality initiatives, and demonstrate Danaher values using DBS tools.

Matching Summary

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

Skills & Requirements

Must-have

  • design control processes
  • ISO 13485
  • FDA 21 CFR 820
  • risk management ISO 14971
  • IEC 62304 compliance
  • immunoassay principles

Nice-to-have

  • continuous improvement culture
  • collaborative team environment
  • mentoring junior team members
  • driving quality initiatives

Key Requirements

  • 5–7 years in Quality Assurance
  • M.Tech /B.Tech/BE degree in engineering
  • proven expertise in regulated environments
  • strong understanding of immunoassay principles

Work Rights

Not specified

Tailored Resume

Cover Letter