Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
Bachelor's degree in engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
Familiarity with internal and external audits, including Notified Body and FDA inspections.