Senior Quality Engineering Manager, Manufacturing Excellence

Edwards Lifesciences Gruppe; Salt Lake City (UT); Sur place; USD 140 000 - 210 000; Plein temps

Résumé du poste

Edwards Lifesciences in Salt Lake City seeks a Senior Manager of Quality Engineering to lead a team of quality engineers supporting our manufacturing operations. You will drive quality and regulatory compliance across major production areas, including THV and related catheters, oversee NCR/CAPA, investigations, and risk management, and partner with Operations and Facilities to sustain compliant production.

You will champion continuous improvement, data-driven decision making, and readiness for

Qualifications

• Bachelor’s degree in a relevant field and extensive quality/regulatory experience in a highly regulated environment.
• Proven leadership of quality engineers and cross-functional teams.
• Experience deploying quality management systems in regulated manufacturing (ISO 13485, 21 CFR Part 820).

Responsabilités

• Lead and develop a team of Quality Engineers for manufacturing operations.
• Provide quality and compliance oversight ensuring procedures meet ISO 13485 and 21 CFR Part 820.
• Oversee NCR, CAPA, investigations, root cause analysis, and timely closure.
• Monitor quality metrics and escalate risks with actionable recommendations.
• Support supplier quality issues and corrective actions with suppliers.
• Assist internal and external audits and maintain inspection readiness.
• Foster a culture of quality, accountability, and continuous improvement.

Connaissances

People leadership

Quality engineering

CAPA leadership

Nonconformance investigations

Root cause analysis

ISO 13485

21 CFR Part 820

Quality data analysis

Audits

Regulatory compliance

Formation

Bachelor's degree in Quality/Manufacturing

Outils

Minitab

MSA

Audit software

Description du poste

Edwards Lifesciences in Salt Lake City seeks a Senior Manager of Quality Engineering to lead a team of quality engineers supporting our manufacturing operations. You will drive quality and regulatory compliance across major production areas, including THV and related catheters, oversee NCR/CAPA, investigations, and risk management, and partner with Operations and Facilities to sustain compliant production.

You will champion continuous improvement, data-driven decision making, and readiness for