Quality Engineer

Responsibilities: SME for Change Control Activities Manage risk assessment and ensure appropriate actions are taken and documented in the QMS Technical resource for NPI and tech transfer activities from a quality perspective Manage equipment and facility suppliers for review/approval of commissioning documentation including qualification and commissioning of facilities, equipment, utilities, Lab, etc. Ensure Environmental Monitoring, Stability, Lab, and Manufacturing are compliant Support CAPA system Requirements: 5+ years of experience in medical device or pharm Strong experience in quality while interfacing with Manufacturing, facilities, etc. SQ preferred