About this role
Staff Design Assurance Quality Engineer at AtriCure. Location: Mason, Ohio, United States. Role: lead risk, ensure compliance, support validation Requirements: Bachelor’s degree in Engineering; 7+ years in a medical device engineering role; knowledge of design controls (FDA QSR 21 CFR Part 820, ISO 13485); risk management (ISO 14971); FMEA, DOE, GR&R; strong communication and collaboration skills; travel up to 10%. Category: Quality Assurance Seniority: Mid Level Tools: FMEA, DOE, GR&R, Statistical analysis, Design Controls, ISO 13485, FDA QSR 21 CFR Part 820, ISO 14971 Certifications: asq, six sigma / design for six sigma Commitment: Full Time Workplace: Onsite Languages: English