Quality Engineer II

About the role

The Quality Engineer II will develop, apply, and maintain quality standards for medical‑device materials and products at our Santa Clara site. You will work cross‑functionally with manufacturing, design, and regulatory teams to ensure product precision, resolve technical issues, and support continuous improvement.

Key responsibilities

• Design and implement inspection, testing, and evaluation procedures for components, sub‑assemblies and finished products.
• Support manufacturing by investigating non‑conformances, managing product disposition, and validating process changes (IQ, OQ, PQ).
• Prepare documentation such as validation protocols, quality plans, defect investigations and inspection plans.
• Participate in risk‑management activities including hazard assessments, design traceability, DV&V testing and FMEA.
• Process customer complaints, conduct root‑cause analysis and drive corrective actions.

Required profile

• Bachelor’s degree in Bioengineering, Biomedical Engineering or a related field.
• Minimum 2 years of experience in a medical‑device quality engineering role.
• Hands‑on experience with failure investigations, production line support and process validation.

Required skills

• Technical writing for investigations, validation protocols and reports.
• Risk‑management documentation (hazard assessment, design trace matrix, FMEA).
• Statistical analysis using Minitab or equivalent tools (process capability, DOE, hypothesis testing).
• Knowledge of ISO, ASTM and FDA quality standards for medical devices.

What we offer

• Competitive salary $105,000‑$115,000 per year.
• Comprehensive medical, dental, vision and retirement benefits.
• Generous paid time off including vacation, holidays, parental and volunteer leave.
• Opportunities for professional development within a global healthcare leader.