Senior Manager, Quality Engineering - Manufacturing Operations (2nd Shift)

Edwards Lifesciences seeks a Senior Manager of Quality Engineering for second-shift manufacturing operations in Salt Lake City. This leadership role oversees quality compliance, manages a Quality Engineer team, and ensures regulatory adherence across multiple production areas including valve and catheter manufacturing.

Responsibilities

• Lead, coach, and develop Quality Engineer team with clear expectations and development plans
• Oversee quality and compliance for second-shift manufacturing across THV, TMTT, catheters, and metals production
• Manage initiation, investigation, and closure of nonconformance reports and CAPAs including root cause determination
• Monitor quality metrics and trends; identify emerging risks and provide recommendations to leadership
• Partner with Operations, Manufacturing Engineering, and other functions to resolve quality issues and maintain compliance

Requirements

• Bachelor's degree in Quality Engineering, Quality Management, or Manufacturing Quality with regulated environment experience
• Demonstrated people leadership managing and developing engineers or quality professionals
• Working knowledge of ISO 13485 and 21 CFR Part 820 in regulated manufacturing
• Strong experience leading CAPAs, nonconformance investigations, and root cause analysis
• Ability to work onsite Monday-Thursday, 3:30 PM to 2:30 AM second-shift schedule
• Medical device manufacturing experience preferred
• Experience with cleanroom operations, microbiology controls, or supplier quality preferred