Quality Engineering Lead - Manufacturing Excellence

Edwards Lifesciences Gruppe

Draper (UT)

On-site

USD 140,000 - 190,000

Full time

3 days ago

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Job summary

Edwards Lifesciences is seeking a Senior Manager of Quality Engineering to lead a team of quality engineers in manufacturing, ensuring adherence to ISO 13485 and 21 CFR Part 820. The role focuses on CAPA, NCRs, and continuous improvement within THV, TMTT, and related production areas.

The ideal candidate will have proven leadership in regulated manufacturing quality, extensive experience with quality systems, and strong collaboration with Operations, Facilities, and Supply Chain to uphold

Qualifications

Bachelor’s degree in a highly regulated environment with quality engineering or manufacturing quality experience.
Demonstrated people leadership experience managing engineers or quality professionals.
Experience deploying or sustaining quality management systems in regulated manufacturing.

Responsibilities

Lead, coach, and develop a team of Quality Engineers in manufacturing operations.
Provide quality and compliance oversight for manufacturing activities per procedures and regulatory standards.
Oversee NCR/CAPA processes, CAPA strategy, and closure.
Lead quality management system deployment and continuous improvement aligned with ISO 13485 and 21 CFR Part 820.
Monitor quality metrics and provide actionable recommendations to leadership.
Support audits and respond to audit findings with corrective actions.