Nobel Biocare Quality Engineer, Manufacturing (On-Site Yorba Linda, CA)
Core
Ensure production processes remain in control and produce medical devices meeting specifications through validation, verification, and continuous improvement.
Role type
Quality Assurance Engineer (Medical Devices Manufacturing)
Builds
Medical devices (dental implants/surgery tools)
Domain
Medical Devices / Manufacturing
Required skills
Root cause analysis (5-Why, Fishbone, Lean, Six Sigma), Risk management (PFMEA), Regulatory standards (ISO 13485, ISO 14971, IEC 60812, 21 CFR 820), Process validation, Non-conformance management, Audit support
Preferred skills
Master's degree, Independent judgment, Risk-based thinking, Statistical analysis
Technologies
PFMEA, 5-Why, Fishbone, Lean, Six Sigma, ISO 13485, ISO 14971, IEC 60812, 21 CFR 820
Responsibilities
Support translation of process risk into PFMEA controls and inspection plans; Ensure validations and verifications are robust; Document and lead root-cause analysis for non-conformances; Partner with engineering to optimize inspection methods; Support NPI and Lifecycle projects; Lead supplier audits.
Seniority
Mid-Senior, hands-on IC