Quality Engineer Intern

Summary: Avive Solutions, Inc. is a growth stage Automated External Defibrillator (AED) company focused on saving lives through innovative technology. The Quality Engineer Intern will support the Quality Assurance team in maintaining and improving the Quality Management System in compliance with medical device regulations. Responsibilities: - Support the maintenance and continuous improvement of the Quality Management System (QMS) by ensuring records, documentation, and quality files are accurate, and complete - Contribute to training program administration by helping ensure training plans are current and employees are meeting compliance requirements - Assist in supplier quality activities, including maintaining supplier documentation and supporting the collection and routing of supplier change notifications and assessment records - Analyze supplier inspection data and update inspection plans - Support nonconformance and complaints root cause investigation activities - Contribute to Corrective and Preventive Action (CAPA) process by organizing and analyzing data, and outlining improvement actions Required Qualifications: - In the process of obtaining a bachelor's or master's degree in an engineering field (e.g. Electrical, Mechanical Engineering, or Biomedical Engineering) - Strong analytical and problem-solving skills with excellent attention to detail - Strong understanding of engineering principles - Strong interpersonal, and communication skills Preferred Qualifications: - Technical knowledge of electromechanical systems and software medical devices Required Skills: Quality Management System (QMS), 21 CFR Part 820, ISO 13485, Engineering principles, Electromechanical systems, Software medical devices