Senior QA/RA Specialist

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

Full-Time | Novato, CA - This role is 100% on-site.

QT Imaging is a medical device company engaged in research, development, and commercialization of innovative body imaging systems using low frequency sound waves. QT Imaging strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient's experience. For more information on QT Imaging, please visit the company's website at www.qtimaging.com

Job Description Overview

We are seeking an experienced Senior QA/RA Specialist to lead Quality Assurance and Regulatory Affairs activities supporting our innovative medical imaging devices. The ideal candidate will have strong experience in medical device regulatory compliance and quality systems and will serve as a key contributor to regulatory submissions, quality system compliance, and cross-functional product development. This role combines hands-on quality responsibilities with increasing ownership of U.S. and international regulatory activities, including FDA, EU MDR, and global market registrations.

Key Responsibilities

• Lead maintenance and continuous improvement of the Quality Management System in alignment with FDA QMSR, ISO 13485, EU MDR, and other applicable global regulatory requirements.


• Prepare, review, and maintain regulatory submissions, technical documentation, product registrations, and regulatory correspondence supporting U.S. and international markets.


• Serve as the primary QA/RA representative on cross-functional project teams, ensuring quality and regulatory requirements are incorporated throughout the product lifecycle.


• Lead document control and change management activities, including review of Engineering Change Orders, Design History Files, and quality system documentation.


• Lead complaint investigations, CAPA activities, nonconformance investigations, and post-market surveillance activities while ensuring regulatory compliance.


• Maintain UDI/GUDID compliance and support international product registrations, renewals, Authorized Representative activities, and regulatory reporting requirements.


• Participate in risk management, design control, supplier quality, and manufacturing quality activities as required.


• Support and participate in FDA inspections, Notified Body audits, customer audits, and internal audits; prepare responses to audit observations and regulatory inquiries.


• Provide regulatory guidance to Engineering, Clinical, Operations, and Commercial teams regarding applicable regulatory requirements and quality system expectations.

Prior Experience

• Experience leading regulatory submissions for FDA, EU MDR, Health Canada, or other international markets.


• Experience with Technical Documentation, Design Dossiers, or Design History Files.


• Experience supporting FDA inspections and Notified Body audits.


• Experience using electronic Quality Management Systems (e.g., Greenlight Guru).


• RAC, ASQ CQE, CQA, or similar professional certification.

Qualifications & Requirements

• Bachelor's degree in engineering, life sciences, or a related field.


• Minimum 5 years of experience in medical device Quality Assurance or Regulatory Affairs (an advanced degree may be considered toward experience requirements).


• Strong knowledge of FDA regulations (21 CFR 820/QMSR), ISO 13485, and EU MDR requirements.

Additional Skills

Location

Novato, CA - This role is 100% on-site.

Job Type

Full-Time

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains "at-will".

QT Imaging Holdings, Inc.
Three Hamilton Landing, Suite 160
Novato, CA 94949
[phone]