Enovis · 2 days ago
Supplier Quality Assurance Engineer
Vista, CA
Full-time
Onsite
Senior Level
5+ years expEnovis Corporation is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions. They are seeking a Supplier Quality Assurance Engineer to manage supplier quality programs, drive compliance, and ensure alignment with product safety and registration requirements.
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
Required
Bachelor's degree in engineering or related technical field (Mechanical, Biomedical, Industrial preferred)
5+ years of experience in supplier quality and/or quality systems within a regulated industry (medical devices preferred)
Strong understanding of FDA QSR, ISO 13485, MDSAP, EU MDR, and applicable global regulations
Experience supporting or leading regulatory inspections (FDA, Notified Bodies, etc.)
Auditor certification (e.g., CQA, lead auditor ISO 13485) required or ability to obtain within 6 months
Experience with product safety standards, registration, and compliance (CE marking, UL, etc.)
Preferred
Bilingual (Spanish/English) a plus
Company
Enovis
Enovis is a medical technology company that develops orthopedic medical devices.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$400M2023-10-20Post Ipo Debt· $400M
2022-04-05IPO
Leadership Team
Damien McDonald
CEO
Mitchell P. Rales
Co-Founder
Recent News
2026-01-22
2026-01-13
2026-01-06
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