Overview
Sr Manager, Quality Assurance Jobs in Aliso Viejo, CA at EPM Scientific
Title: Sr Manager, Quality Assurance
Company: EPM Scientific
Location: Aliso Viejo, CA
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.
