p>Experience and Qualifications: Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or related field 2-5 years of quality engineering experience in the medical device or regulated industry Working knowledge of ISO 13485, FDA QSR (21 CFR 820), and design controls Experience with CAPA, audits, document control, and risk management Strong written and verbal communication skills.
Support Design Controls activities (requirements, risk management, verification & validation) Participate in risk management (ISO 14971) activities, including FMEA and hazard analysis Review design documentation for compliance and completeness Assist as needed with Test and Inspection.