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Danaher UK is seeking a Lead Systems Quality Engineer for their Cepheid division in Bengaluru, India. The role focuses on design validation activities in compliance with FDA and ISO regulations, emphasizing continuous improvement in the life sciences and biotechnology sectors.
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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.
Candidates will participate in internal and external audits while driving continuous improvements based on evolving business needs and guidelines.
Matching Summary
Match Score: 75
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Danaher UK is seeking a Lead Systems Quality Engineer for their Cepheid division in Bengaluru, India. The role focuses on design validation activities in compliance with FDA and ISO regulations, emphasizing continuous improvement in the life sciences and biotechnology sectors.
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Skills & Requirements
Must-have
7+ years regulated industry experience
Design controls proficiency 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 usage
Continuous improvement mindset
Cross-functional collaboration skills
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
Leading design validation and risk management activities