Top Career Solutions has teamed with a leading Medical Device company to hire a Quality Engineer. This person will develop and maintain quality systems to ensure compliance with FDA and ISO requirements. This is a direct hire opportunity located in the Twin Cities.
Duties:
· Perform first article inspections and montior incoming material
· Ensure FDA and ISO requirements are being met by performing failure analysis and statistical process control
· Perform product audits while monitoring correct criteria
· Develop company quality manual
· Analyze quality data and perform corrective action
· Communicate directly with customers to resove product quality issues
Requirements:
· Bachelor’s Degree in Engineering
· 5+ years experience as Quality Engineer
· Experience in Medical Device and Electronics is required
· Working knowledge of ISO 13485 requirements
· Project Management and Process Analysis is preferred
