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Qa Ra Specialist Jobs (NOW HIRING)

QT Imaging, Inc.

Senior QA/RA Specialist

Novato, CA · On-site

$125 - $150/hr

For more information on QT Imaging, please visit the company's website at www.qtimaging.com Overview We are seeking an experienced Senior QA/RA Specialist to lead Quality Assurance and Regulatory ...

MMQCI

Quality Assurance Specialist

Saco, ME · On-site

$80 - $100/hr

Ensure Quality & Compliance as Our Next QA/RA Specialist! The Quality Assurance/Regulatory Affairs Specialist plays a key role in supporting quality assurance activities and ensuring compliance with ...

MMQCI

Quality Assurance Specialist

Saco, ME · On-site

$27.88 - $53.85/hr

Ensure Quality & Compliance as Our Next QA/RA Specialist! The Quality Assurance/Regulatory Affairs Specialist plays a key role in supporting quality assurance activities and ensuring compliance with ...

Ketryx

QA/RA Consultant

Boston, MA · On-site +1

$130K - $150K/yr

Job Title: QA/RA Consultant Employment Status: Full-time Office Hours: Monday - Friday; hybrid ... specialist role. * Familiar with eQMS implementation, validation and implementation. * Deep ...

Transformcap

QA/RA Consultant

Boston, MA · On-site

$125 - $150/hr

Job Title: QA/RA Lead Employment Status: Full-time Office Hours: Monday - Friday; hybrid schedule ... specialist role * Familiar with eQMS implementation, validation and implementation. * Deep ...

Ketryx

QA/RA Consultant

Boston, MA · On-site

$130K - $150K/yr

Job Title: QA/RA Consultant Employment Status: Full-time Office Hours: Monday - Friday; hybrid ... specialist role. * Familiar with eQMS implementation, validation and implementation. * Deep ...

TriMas Corporation

Senior Quality Engineer

Clinton, MI · On-site

$87K - $118K/yr

... QA/RA Specialist and/or quality assurance positions. Experience must include: ISO-13485 standards and 21 CFR-820 regulatory compliance; ISO 14971 and risk management, such as pFMEA, Control Plans ...

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Qa Ra Specialist information

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$31.5K

$71.3K

$117K

How much do qa ra specialist jobs pay per year?

As of Sep 8, 2026, the average yearly pay for qa ra specialist in the United States is $71,279.00, according to ZipRecruiter salary data. Most workers in this role earn between $57,000.00 and $84,500.00 per year, depending on experience, location, and employer.

What is a QA RA specialist?

QA RA Specialists, or Quality Assurance and Regulatory Affairs Specialists, are professionals responsible for ensuring that products, particularly in industries like pharmaceuticals and medical devices, meet quality standards and comply with regulatory requirements. They develop and implement quality control procedures, review documentation, and coordinate with regulatory agencies to ensure products are safe and effective for consumers. Their work helps companies avoid legal issues and maintain high standards of safety and quality throughout the product lifecycle.

What are the key skills and qualifications needed to thrive as a QA RA specialist?

To thrive as a QA/RA Specialist, you need a solid background in quality assurance and regulatory affairs, often supported by a degree in life sciences or engineering and familiarity with industry standards. Proficiency with quality management systems (QMS), regulatory submission tools, and knowledge of ISO, FDA, or EU MDR regulations is typically required. Strong attention to detail, effective communication, and problem-solving skills help you manage compliance issues and collaborate with cross-functional teams. These skills ensure that products meet regulatory requirements and maintain high-quality standards, safeguarding both company reputation and consumer safety.

How do QA RA specialists typically collaborate with cross-functional teams during product development?

QA RA Specialists regularly work with engineering, manufacturing, and marketing teams to ensure product designs meet regulatory standards and quality requirements. They review technical documentation, participate in risk assessments, and provide guidance on compliance throughout the development process. Clear communication and proactive involvement help prevent delays and ensure products are ready for regulatory submission and market release.
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Qa Ra Specialist jobs near you
Infographic showing various Qa Ra Specialist job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 84% Full Time, 13% Part Time, and 2% Contract. Highlights an 82% Physical, 2% Hybrid, and 16% Remote job distribution, with an average salary of $71,279 per year, or $34.3 per hour.

Senior QA/RA Specialist

QT Imaging, Inc.

Novato, CA • On-site

$125 - $150/hr

Other

Posted 7 days ago

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
+1 (415) 842-7250
#J-18808-Ljbffr

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