Apply on Employer Site

Enovis · 1 week ago

Supplier Quality Assurance Engineer

Vista, CA

Full-time

Onsite

Senior Level

5+ years exp

Enovis Corporation is an innovation-driven medical technology growth company focused on developing solutions that improve patient outcomes. The Supplier Quality Assurance Engineer will manage supplier quality programs, drive compliance, and lead audits to ensure alignment with product safety and registration requirements in the medical device industry.

Health CareManufacturingMedicalMedical DeviceProduct Design

No H1B

Responsibilities

Lead supplier audits, assessments, and corrective action processes (SCARs)

Manage supplier performance metrics, scorecards, and improvement plans

Support product safety registration processes (e.g., CE, UL, FDA submissions), including coordination with Regulatory Affairs

Own and drive the site’s CAPA, NCMR, and training processes

Support the development and validation of supplier-provided components and materials

Drive root cause investigations for supplier-related nonconformances (NCMRs, SCARs)

Collaborate with R

Lead and support internal audits; coordinate and prepare for external and regulatory body inspections (FDA, ISO, MDSAP)

Qualification

Supplier Quality ManagementQuality SystemsFDA QSRISO 13485Regulatory InspectionsAuditor CertificationProduct Safety StandardsRoot Cause AnalysisBilingual (Spanish/English)Collaboration