Senior Manager, Quality Engineering - Manufacturing Operations
Edwards Lifesciences · Salt Lake City, UT
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Edwards Lifesciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.