Director, Quality Engineering – Medical Devices

Edwards; Salt Lake City (UT); On-site; USD 140,000 - 180,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Manager, Quality Engineering to lead a team of Quality Engineers in a highly regulated manufacturing environment. You will drive quality and compliance oversight across major production areas and partner with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain.

The role emphasizes NCR/CAPA execution, investigation quality, and data-driven quality management to strengthen operational controls and ensure inspection readiness for

Qualifications

• Bachelor’s degree in Quality Engineering or related field; or equivalent experience.
• Demonstrated people leadership experience managing and developing engineers or other quality professionals.
• Experience deploying or sustaining quality management systems in regulated manufacturing (ISO 13485, 21 CFR Part 820).
• Strong experience leading CAPAs and nonconformance investigations with root cause analysis.

Responsibilities

• Lead, coach, and develop a team of Quality Engineers supporting manufacturing operations.
• Provide quality and compliance oversight for manufacturing activities per procedures and regulatory standards.
• Oversee NCR and CAPA initiation, investigation, approval, and closure with root cause analysis and corrective actions.
• Own CAPA strategies, action planning, implementation, and effectiveness verification.
• Lead quality systems deployment and continuous improvement aligned with ISO 13485 and 21 CFR Part 820.
• Monitor quality metrics and provide actionable recommendations to operations and leadership.

Skills

People leadership

Quality management

Regulatory compliance

Root cause analysis

CAPA management

Education

Bachelor's degree in Quality Engineering or related field

Tools

IQ/OQ/PQ processes

Job description

Edwards Lifesciences is seeking a Senior Manager, Quality Engineering to lead a team of Quality Engineers in a highly regulated manufacturing environment. You will drive quality and compliance oversight across major production areas and partner with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain.

The role emphasizes NCR/CAPA execution, investigation quality, and data-driven quality management to strengthen operational controls and ensure inspection readiness for