Minneapolis, MN30+ days ago
WHAT YOU CAN BRING TO OUR GREAT TEAM Required: Minimum of 15 years working in medical device quality systems Minimum of 10 years managerial experience Minimum of 5 y ars in a medical device compliance and/or audit role Experience working directly with FDA, Notified Bodies or other geographic regulators during regulatory inspections/audits (front room) In depth knowledge of and implementing global medical device regulations (21 CFR 11, 820, 801, 803, 806, 821, 822, 830, JPAL, EU MDR, MDSAP, ISO 13485, etc.) Demonstrated leadership and project management skills with the ability to prioritize and execute. This position involves leading teams responsible for configuration assurance, quality systems compliance, QMS training and audit, quality operations, non-product software design assurance and eQMS development and implementation, ensuring compliance with global regulations and driving continuous improvement.