Lead Systems Quality Engineer

Danaher

Bengaluru, India
Not specified
7+ years regulated industry experience
Design controls proficiency
Iso-14971 iso-60601 iso-62366 iso-13485 iec-63000 knowledge
Danaher is seeking a Lead Systems Quality Engineer for its Cepheid division in Bengaluru, India, focusing on design validation within the life sciences and biotechnology sectors. The role involves ensuring compliance with FDA and ISO regulations while collaborating with cross-functional teams to improve health care through innovative solutions

Job Summary

  • The Lead Systems Quality Engineer supports design validation activities for assay, instrument, and software development while ensuring FDA and ISO regulatory compliance.
  • This role involves defining design validation strategies, overseeing test architecture from a system perspective, and conducting safety risk analyses within the Quality department.
  • Candidates will participate in internal and external audits as a subject matter expert and drive continuous improvements based on evolving business needs and regulatory guidelines.

Matching Summary

Match Score: 85

Danaher is seeking a Lead Systems Quality Engineer for its Cepheid division in Bengaluru, India, focusing on design validation within the life sciences and biotechnology sectors. The role involves ensuring compliance with FDA and ISO regulations while collaborating with cross-functional teams to improve health care through innovative solutions.

Skills & Requirements

Must-have

  • 7+ years regulated industry experience
  • Design controls proficiency
  • ISO-14971 ISO-60601 ISO-62366 ISO-13485 IEC-63000 knowledge
  • Complex project release cycle experience
  • Design validation strategy definition
  • Safety risk analysis participation

Nice-to-have

  • ASQ Quality Engineering certification
  • Agile software tool experience
  • Complaint tracking system expertise
  • Requirements management tools
  • Defect tracking systems familiarity

Key Requirements

  • BA/BS degree in Science or Engineering
  • 7+ years working experience in regulated industry
  • Proficiency in Design controls and ISO regulations
  • Experience leading design validation and risk management

Work Rights

Not specified

Tailored Resume

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