Senior Quality Engineering Leader, 2nd Shift

Edwards Lifesciences; Salt Lake City, Northern (UT, KY); Hybrid; USD 140,000 - 170,000; Full time

Job summary

Edwards Lifesciences in Utah is seeking a Senior Manager, Quality Engineering (2nd Shift) to lead a team of Quality Engineers and oversee quality and compliance across second-shift manufacturing operations.

You will partner with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain to ensure compliant production, robust NCR/CAPA processes, and continuous improvement aligned with ISO 13485 and 21 CFR Part 820.

Qualifications

• Bachelor’s degree in Quality Engineering, Quality Management, or Manufacturing Quality.
• Proven people leadership experience coaching engineers.
• Experience deploying quality management systems in regulated manufacturing (ISO 13485, 21 CFR Part 820).
• Strong CAPA and nonconformance investigation leadership.
• Willingness to onsite for 2nd shift (Mon-Thu, 3:30 PM–2:30 AM).

Responsibilities

• Lead and develop a team of Quality Engineers for 2nd shift manufacturing operations.
• Oversee NCR/CAPA execution and investigate root causes.
• Maintain compliance with ISO 13485 and 21 CFR Part 820.
• Monitor quality metrics and drive continuous improvement.
• Prepare for internal and external audits and respond to findings.

Skills

People leadership

Quality engineering

Regulatory compliance

CAPA management

Root cause analysis

Education

Bachelor's degree in Quality/Manufacturing

Tools

QMS systems

Job description

Edwards Lifesciences in Utah is seeking a Senior Manager, Quality Engineering (2nd Shift) to lead a team of Quality Engineers and oversee quality and compliance across second-shift manufacturing operations.

You will partner with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain to ensure compliant production, robust NCR/CAPA processes, and continuous improvement aligned with ISO 13485 and 21 CFR Part 820.