Quality Specialist/Coordinator

QT Imaging, Inc.; Novato (CA); Hybrid; USD 75,000 - 100,000; Full time

Job summary

QT Imaging, Inc. is a medical device company focused on innovative body imaging systems using low frequency sound waves. We are seeking a Quality Specialist/Coordinator to support the Quality Management System in a 100% on-site role in Novato, CA.

You will help ensure regulatory compliance, document control, training records, and audit readiness across the organization. Ideal candidates bring strong attention to detail and experience in regulated environments, with familiarity with FDA QMSR and

Qualifications

• Strong attention to detail.
• Experience working in a regulated environment.
• Experience with good documentation practices.

Responsibilities

• Follow processes of the Quality Management System in alignment with FDA QMSR, ISO 13485, and global regulatory expectations
• Provide cross-functional support for quality functions
• Support the training management workstream by collecting and logging training records, notifying employees of training requirements, and generating training reports
• Support the document management function by processing engineering change requests ensuring accurate updating and management of files
• Support the review and closure of customer incidents and events (complaints)
• Support the filing and management of material traceability documentation
• Participate in preparing for and supporting FDA inspections, ISO audits, and major customer audits

Skills

Attention to detail

Regulated environment experience

Good documentation practices

Tools

Document management systems

Job description

Contract, 40 hrs/wk | Novato, CA - Note: 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 a Quality Specialist/Coordinator to support the Quality Management System. The ideal candidate will bring strong attention to detail, proactive attitude, and experience working in a regulated environment. This role is a great way to develop strong quality skills in the medical device industry while helping the company provide much needed diagnostic products for patients.

Reports to: VP of Quality

Key Responsibilities

• Follow processes of the Quality Management System in alignment with FDA QMSR, ISO 13485, and global regulatory expectations
• Provide cross-functional support for quality functions
• Support the training management workstream by collecting and logging training records, notifying employees of training requirements, and generating training reports
• Support the document management function by processing engineering change requests ensuring accurate updating and management of files
• Support the review and closure of customer incidents and events (complaints)
• Support the filing and management of material traceability documentation
• Participate in preparing for and supporting FDA inspections, ISO audits, and major customer audits

Prior Experience

Qualifications & Requirements

• Strong attention to detail
• Experience working in a regulated environment
• Experience with good documentation practices

Additional Skills

• Experience using document management tools and systems
• Experience supporting audit activities
• Experience supporting internal customers

Salary Range

Job Type

Contract, 40 hrs/wk

Location

Novato, CA – Note: This role is 100% on-site

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]