Lead Qa Systems Validation Engineer

Danaher

Bengaluru, India
On-site
7+ years regulated industry experience
Design controls proficiency
Iec-62304 knowledge
The Lead QA Systems Validation Engineer position at Danaher, specifically within Cepheid, involves leading quality systems activities for software development projects focused on regulatory compliance. The role requires significant experience in design controls and risk management within a regulated industry, aiming to improve healthcare through innovative diagnostic solutions

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 the project core team to identify safety and security risks through formal risk assessments per SOPs.
  • Candidates must have proven history working in a wet lab and experience leading design validation activities.

Matching Summary

Match Score: 85

The Lead QA Systems Validation Engineer position at Danaher, specifically within Cepheid, involves leading quality systems activities for software development projects focused on regulatory compliance. The role requires significant experience in design controls and risk management within a regulated industry, aiming to improve healthcare through innovative diagnostic solutions.

Skills & Requirements

Must-have

  • 7+ years regulated industry experience
  • Design controls proficiency
  • IEC-62304 knowledge
  • ISO-14971 and ISO-13485 regulations
  • Wet lab experience required
  • Risk management leadership

Nice-to-have

  • ASQ Quality Engineering certification
  • Molecular diagnostics experience
  • CRE or CQA certification
  • Continuous improvement culture
  • Global scale impact focus

Key Requirements

  • BA/BS degree in Science or Engineering
  • 7+ years working experience in regulated industry
  • Proficiency in Design controls and IEC-62304
  • Knowledge of ISO-14971 and ISO-13485
  • Proven history working in a wet lab

Work Rights

Not specified

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