Senior Manager, Quality Engineering - Manufacturing Operations

Edwards Lifesciences seeks a Senior Manager, Quality Engineering to lead quality and compliance operations at a manufacturing facility producing structural heart devices. This role combines people leadership of a Quality Engineering team with direct oversight of manufacturing quality, regulatory compliance, and continuous improvement initiatives across multiple product lines.

Responsibilities

• Lead, coach, and develop a team of Quality Engineers supporting manufacturing operations with clear expectations and accountability
• Oversee nonconformance reports, investigations, root cause determination, and corrective actions across manufacturing areas
• Lead CAPA deployment, implementation, effectiveness verification, and sustainable closure across the organization
• Monitor quality metrics, trends, and emerging risks; provide actionable recommendations to Operations and Quality leadership
• Partner with Operations, Manufacturing Engineering, and Facilities to resolve quality issues and maintain compliant production

Requirements

• Bachelor's degree in Quality Engineering, Quality Management, Manufacturing Quality, or equivalent regulated industry experience
• Demonstrated people leadership experience managing and developing engineers or technical quality professionals
• Experience deploying, implementing, or sustaining quality management systems in regulated manufacturing, including ISO 13485 and 21 CFR Part 820 knowledge
• Strong experience leading CAPAs, nonconformance investigations, and structured root cause analysis with investigation quality evaluation
• Medical device manufacturing experience preferred
• Experience with process validations, test method validations, and measurement system analysis reviews preferred