QA Engineer

About the role

Join BVI®, a global leader in ophthalmic devices, as a QA Engineer. You will ensure product quality and regulatory compliance while supporting surgical teams worldwide.

Key responsibilities

• Determine project quality requirements and lead quality planning activities.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA).
• Participate in internal and external audits, including FDA and supplier audits.
• Maintain and improve statistical process control, PFMEA, QFD, and risk‑based management tools.
• Monitor industry standards and emerging trends to drive continuous improvement.
• Build and sustain relationships with internal stakeholders and external partners.

Required profile

• 5+ years of experience in quality, engineering, regulatory or operations within a manufacturing environment.
• BS/BA degree or higher in engineering, quality, biomedical or a related field.
• Bilingual proficiency in English and Spanish.
• Strong knowledge of ISO 13485, MDSAP, MDR and other international standards.
• Proven ability to work flexibly and adapt quickly to changing priorities.

Required skills

• Root Cause Analysis
• Corrective and Preventive Action (CAPA)
• ISO 13485, MDSAP, MDR
• Lean and Six Sigma methodologies
• Statistical Process Control (SPC)
• Process Failure Mode Effects Analysis (PFMEA)
• Quality Function Deployment (QFD)
• Risk‑based management
• Internal and external audit experience (FDA, suppliers)
• ASQ certifications (CQE, CQM/OE, CSQE, CQA, CRE)