Senior Medtech QA/RA Lead — On-site Novato

QT Imaging, Inc.; Novato (CA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

QT Imaging Holdings, Inc. in Novato, CA seeks a Senior QA/RA Specialist to lead quality assurance and regulatory affairs for its medical imaging devices. The role combines hands-on quality work with growing ownership of FDA and international submissions, quality systems, and risk management.

You will maintain the QMS in alignment with FDA QMSR and ISO 13485, manage design history files, and support inspections, audits, and registrations across markets.

Qualifications

• Experience leading regulatory submissions for FDA and international markets.
• Strong knowledge of FDA 21 CFR 820/QMSR, ISO 13485, and EU MDR.
• Proven ability to manage Design History Files and technical documentation.

Responsibilities

• Lead maintenance and improvement of the Quality Management System.
• Prepare and manage regulatory submissions and product registrations.
• Support FDA inspections, Notified Body audits, and post-market activities.

Skills

Regulatory Affairs

Quality Assurance

FDA Regulations

Education

Bachelor's degree

Tools

Greenlight Guru

Job description

QT Imaging Holdings, Inc. in Novato, CA seeks a Senior QA/RA Specialist to lead quality assurance and regulatory affairs for its medical imaging devices. The role combines hands-on quality work with growing ownership of FDA and international submissions, quality systems, and risk management.

You will maintain the QMS in alignment with FDA QMSR and ISO 13485, manage design history files, and support inspections, audits, and registrations across markets.