Supplier Quality Assurance Engineer

Enovis • Vista, CA

53d • Onsite

About The Position

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together. As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. We are seeking a dynamic Supplier Quality & Quality Systems Engineer to manage supplier quality programs and drive compliance and performance across our site's quality system. This role supports supplier qualification and performance, leads internal and external audits, facilitates regulatory body inspections, and ensures alignment with product safety and registration requirements. The ideal candidate will be experienced in both supplier quality and quality systems within the medical device industry.

Requirements

• 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

Nice To Haves

• Experience with product safety standards, registration, and compliance (CE marking, UL, etc.)
• Bilingual (Spanish/English) a plus

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees