Support manufacturing and work cross-functionally to resolve technical problems
Work closely with product development teams
Monitor priorities and track progress against schedules; and communicates status to management
Provide support in the implementation and policing of GMP, ISO and FDA requirements
Experience and excellent understanding of pFMEAs, Root Cause, CAPAs, Non-Conformance, and Process
Experience with product investigation, identifying root cause and implementing appropriate solutions

🎯 Requirements

Minimum Education: Bachelor's in engineering or STEM
Advanced degree preferred with 2+ years of working experience in Quality Engineering or related
Minimum 2 years in medical device environment
Experience with design control and risk management
Demonstrated experience with electromechanical devices
Experience with ISO 13485, ISO 14971, FDA Quality System Regulations

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