Sr Manager, Quality Assurance

Senior Manager, Quality Assurance

📍 Aliso Viejo, CA (On-site)

A fast-growing med device company developing innovative minimally invasive vascular technologies is expanding its Quality leadership team amid strong commercial growth and pipeline advancement.

Why this role stands out

• Lead and scale the QMS in a company moving into commercialization
• High-impact role with executive visibility
• Support cutting-edge, life-saving vascular therapies
• Opportunity to build, refine, and elevate quality systems

Key focus areas

• Own QMS (FDA 21 CFR 820, ISO 13485)
• Drive CAPA, complaints, MDRs, audits
• Partner with R&D, Regulatory, and Ops
• Lead risk management (ISO 14971) & quality metrics

Background

• 7+ years in medical device quality
• Strong QMS / regulatory expertise
• Experience in fast-paced or growth-stage environments

This is a strong opportunity to step into a visible leadership role driving quality for a company bringing impactful vascular innovations to market.

If you feel you'd make a good fit for this role based on your background in Quality at the leadership level, please apply.