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Danaher Corp is seeking a Lead Systems Quality Engineer for its Cepheid division in Bengaluru, India. The role focuses on design validation in compliance with FDA and ISO regulations, requiring extensive experience in quality engineering within regulated industries.
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Job Summary
The Lead Systems Quality Engineer supports design validation activities for assay, instrument, and software development within the life sciences sector.
This role requires leading design validation strategies and conducting safety risk analysis to ensure FDA and ISO regulatory compliance.
Cepheid offers comprehensive benefit programs and a culture of belonging that fosters career growth and continuous improvement.
Matching Summary
Match Score: 75
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Danaher Corp is seeking a Lead Systems Quality Engineer for its Cepheid division in Bengaluru, India. The role focuses on design validation in compliance with FDA and ISO regulations, requiring extensive experience in quality engineering within regulated industries.
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Skills & Requirements
Must-have
7+ years regulated industry experience
Design controls expertise required
ISO-14971 ISO-60601 ISO-13485 knowledge
System level design validation leadership
Safety and security risk analysis
Nice-to-have
ASQ Quality Engineering certification
Agile software tool experience
Complaint tracking system proficiency
Continuous improvement culture fit
Key Requirements
BA/BS degree in Science or Engineering
7+ years working experience in regulated industry
Proficiency in ISO-14971, ISO-60601, ISO-62366, ISO-13485, IEC-63000
Experience with complex projects in multiple release cycles