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

Edwards Lifesciences · Salt Lake City, UT

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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Date posted22 days ago

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