Regulify.AI · 1 day ago
Quality Engineer (AI Products – Medical Technology)
Regulify.AI is revolutionizing how MedTech products are brought to market by optimizing regulatory-compliant processes. The Quality Engineer will focus on implementing and maintaining quality processes to ensure regulatory compliance and product excellence, including performing quality control assessments and developing quality assurance protocols.
Responsibilities
Performing quality control assessments
Developing systematic quality assurance protocols
Monitoring product quality standards
Contributing to the overall quality management system to support successful product deployment
Qualification
Required
Proficiency in Quality Engineering and expertise in implementing quality practices tailored for AI and MedTech products
Strong background in Quality Control and Quality Assurance to ensure compliance with industry standards
Experience in monitoring and improving Product Quality and refining processes to meet established benchmarks
Knowledge of Quality Management systems to ensure operational and regulatory compliance
Excellent analytical, organizational, and problem-solving skills
Ability to work in a collaborative, hybrid work environment and effectively communicate with cross-functional teams
Degree in Engineering, Quality, or a related field or equivalent professional experience in the MedTech industry
Preferred
Familiarity with regulatory standards such as ISO 13485 or FDA regulations is highly desirable