Quality Engineer (AI Products – Medical Technology) jobs in United States
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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.

Artificial Intelligence (AI)Generative AIHealth CareMedical DeviceSoftware
Hiring Manager
Kundan Krishna
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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

Quality EngineeringQuality ControlQuality AssuranceQuality Management SystemsRegulatory StandardsAnalytical SkillsOrganizational SkillsProblem-Solving SkillsCollaborative SkillsCommunication Skills

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

Company

Regulify.AI

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SaaS B2B Med-Tech AI startup

Funding

Current Stage
Early Stage
Total Funding
$0.1M
2025-08-01Pre Seed· $0.1M

Leadership Team

K
Kundan Krishna
Co-Founder
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Company data provided by crunchbase