This is a full-time role for a Quality Engineer at NeuroOne Medical Technologies Corporation. Strong preference is for local candidates, or candidates willing to relocate (Eden Prairie, Minnesota).

Key Responsibilities:

• Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 11, 21 CFR part 803, 21 CFR part 806, 21 CFR part 820) and other applicable standards
• Quality assurance support in the design and development of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of the design and development plan
• Supplier Quality Management of contract manufacturers, including initial qualification, requalification, supplier corrective actions, change notification, and supplier audits
• Support quality audits and regulatory inspections by FDA and Certification Bodies
• Leading investigations in support of Root Cause Analysis, CAPA, and Control of Nonconforming Materials
• Coordinating CAPA implementation, documentation, and effectiveness verification
• Post-Market Surveillance and Post-Market Clinical Follow Up Plans and Reports

Qualifications:

• BS in Engineering, Sciences, or other applicable field, and 3 to 8 years of experience in the regulated medical device industry as a Quality Assurance Engineer (or similar) is preferred
• Excellent Quality System knowledge required. Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, ISO 14971, and other applicable standards
• Working knowledge of principles, concepts, and practices for design and development activities, Risk Management, Root Cause Analysis, and application of ISO Standards
• Proficiency in Microsoft Word, Excel, PowerPoint