Senior Quality Engineering Leader, Medical Devices

Edwards Lifesciences; Salt Lake City (UT); Vor Ort; USD 140.000 - 200.000; Vollzeit

Zusammenfassung

Edwards Lifesciences is seeking a Senior Manager, Quality Engineering to lead a team of Quality Engineers in a highly regulated manufacturing environment. You will ensure quality and compliance across major production areas, drive CAPA execution, and strengthen NCR performance while partnering with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain.

The role emphasizes establishing and sustaining ISO 13485 and 21 CFR Part 820 compliant processes, data-driven quality

Qualifikationen

• Bachelor’s degree with relevant Quality Engineering, Quality Management, or Manufacturing Quality experience in a highly regulated environment.
• 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, nonconformance investigations, and root cause analysis.

Aufgaben

• 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 NCRs, CAPAs, and investigations, ensuring timely closure and effectiveness.
• Lead quality management system deployment and continuous improvement aligned with ISO 13485 and 21 CFR Part 820.
• Monitor quality metrics, trends, and investigations; propose actionable recommendations to leadership.
• Support audits and ensure operations remain inspection-ready; address audit observations.
• Partner with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain to resolve quality issues.
• Establish shift-to-shift communication and escalation for quality and production information.
• Provide quality leadership for supplier-related issues and supplier performance.

Kenntnisse

People leadership

Quality engineering

CAPA management

Root cause analysis

Regulatory quality

Quality metrics

Audits

Ausbildung

Bachelor's degree in a related field

Jobbeschreibung

Edwards Lifesciences is seeking a Senior Manager, Quality Engineering to lead a team of Quality Engineers in a highly regulated manufacturing environment. You will ensure quality and compliance across major production areas, drive CAPA execution, and strengthen NCR performance while partnering with Operations, Manufacturing Engineering, Facilities, Maintenance, and Supply Chain.

The role emphasizes establishing and sustaining ISO 13485 and 21 CFR Part 820 compliant processes, data-driven quality