Quality Assurance Engineer
| Company | ENOVIS |
|---|---|
| Location | Oceanside, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
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
- 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)
Preferred Qualifications
- Bilingual (Spanish/English) a plus