Senior Quality Engineering Lead, 2nd Shift

Edwards Lifesciences; Draper (UT); On-site; USD 140,000 - 190,000; Full time

Job summary

Edwards Lifesciences seeks a Senior Manager, Quality Engineering to oversee second-shift quality across manufacturing operations and develop a team of Quality Engineers. You will partner with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain to ensure compliant, safe, and effective production.

You will strengthen NCR and CAPA execution, improve investigations, monitor quality metrics, and ensure strong shift-to-shift communication between first- and second-shift

Qualifications

• Bachelor’s degree with relevant Quality Engineering, Quality Management, or Manufacturing Quality experience in regulated environment.
• Demonstrated people leadership experience managing engineers or quality professionals.
• Experience deploying quality management systems and knowledge of ISO 13485 and 21 CFR Part 820.
• Strong CAPA, nonconformance investigations, and root cause analysis experience.
• Ability to work onsite for second-shift schedule, Monday–Thursday 3:30 PM–2:30 AM.

Responsibilities

• Lead, coach, and develop a team of Quality Engineers for second-shift manufacturing operations.
• Provide quality and compliance oversight for second-shift activities in accordance with procedures and regulatory standards.
• Oversee NCR/CAPA processes including investigation quality and timely closure.
• Lead CAPAs, including root cause analysis and action planning.
• Improve quality management systems per ISO 13485 and 21 CFR Part 820.
• Review test methods validations and measurement systems analyses.
• Monitor quality metrics and provide actionable recommendations to leadership.
• Support audits and respond to audit observations.
• Collaborate with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain to resolve quality issues.
• Establish effective shift-to-shift communication.

Skills

People leadership

Quality management

CAPA leadership

Root cause analysis

Regulatory compliance

Onsite leadership

Education

Bachelor’s degree in Quality Engineering or Manufacturing Quality

Job description

Edwards Lifesciences seeks a Senior Manager, Quality Engineering to oversee second-shift quality across manufacturing operations and develop a team of Quality Engineers. You will partner with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain to ensure compliant, safe, and effective production.

You will strengthen NCR and CAPA execution, improve investigations, monitor quality metrics, and ensure strong shift-to-shift communication between first- and second-shift