Lead Qa Systems Validation Engineer

Danaher Corp

Bengaluru, India
On-site
Design controls experience
Iec-62304 regulation knowledge
Iso-14971 risk management
The job posting is for a Lead QA Systems Validation Engineer at Danaher Corp in Bengaluru, India, focusing on quality systems for software development in the life sciences sector. The ideal candidate will possess extensive experience in regulated industries and be proficient in design controls and risk management

Job Summary

  • The Lead QA Systems Validation Engineer will lead quality systems activities related to multiple software development projects with a focus on design control and risk management.
  • This role requires collaboration with Regulatory Affairs to develop packages for software 510(k) and PMA submissions while ensuring compliance with FDA and ISO regulations.
  • Candidates must have proven history working in a wet lab and possess proficiency in Design controls, IEC-62304, ISO-14971, and ISO-13485 regulations.

Matching Summary

Match Score: 85

The job posting is for a Lead QA Systems Validation Engineer at Danaher Corp in Bengaluru, India, focusing on quality systems for software development in the life sciences sector. The ideal candidate will possess extensive experience in regulated industries and be proficient in design controls and risk management.

Skills & Requirements

Must-have

  • Design controls experience
  • IEC-62304 regulation knowledge
  • ISO-14971 risk management
  • ISO-13485 compliance
  • Wet lab experience required
  • FDA regulatory submissions

Nice-to-have

  • ASQ Quality Engineering certification
  • Molecular diagnostics background
  • CRE or CQA certification
  • Continuous improvement culture
  • Team mentorship skills

Key Requirements

  • BA/BS degree in Science or Engineering
  • 7+ years in regulated industry
  • Wet lab experience
  • Leadership of validation activities
  • Risk management expertise

Work Rights

Not specified

Tailored Resume

Cover Letter