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Medical Device Quality Assurance Jobs (NOW HIRING)

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 ... About You: You're a proven QMS expert who's successfully navigated complex medical device ...

MRINetwork

Quality Assurance Manager

Itasca, IL · On-site

Stay current with regulatory changes, standards updates, and best practices in medical device ... quality assurance within the medical device industry, including building and managing QMS systems.

New

Ketryx

QA/RA Consultant

Boston, MA · On-site

$130K - $150K/yr

  • Medical

  • PTO

You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... medical device standards. ● Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities. ● Lead ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... medical device standards. ● Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities. ● Lead ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... medical device standards. ● Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities. ● Lead ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... medical device standards. ● Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities. ● Lead ...

MRINetwork Jobs

Quality Assurance Manager

Itasca, IL · On-site

... medical device standards. ● Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities. ● Lead ...

Saxon Global

QA ENGINEER

Saint Augustine, FL

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

W. L. Gore & Associates, Inc.

Regulated QA

Phoenix, AZ · On-site

Regulated QA Req Id: 2080 State/Province: Arizona Business: Gore Medical Products Category: Supply ... Demonstrated working knowledge of FDA medical device quality system regulations and ISO medical ...

New

Stark Pharma Solutions Inc

Quality Technician

Minneapolis, MN · On-site

$18.75 - $25.25/hr

Minneapolis, MN Duration: Long Term Job Overview We are seeking a Quality Technician with experience in the medical device industry to support quality assurance activities, product investigations ...

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Medical Device Quality Assurance information

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How much do medical device quality assurance jobs pay per hour?

As of Aug 19, 2026, the average hourly pay for medical device quality assurance in the United States is $29.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.75 and $34.38 per hour, depending on experience, location, and employer.

What is a medical device quality assurance?

A Medical Device Quality Assurance (QA) job ensures that medical devices meet regulatory standards, quality requirements, and safety guidelines before they reach the market. QA professionals develop and implement quality systems, conduct audits, review documentation, and collaborate with regulatory bodies to maintain compliance with standards like ISO 13485 and FDA regulations. Their role is crucial in preventing defects, ensuring patient safety, and improving product reliability.

What does a medical device quality assurance do?

Professionals in Medical Device Quality Assurance typically review and update quality management systems, conduct internal audits, oversee corrective and preventive action (CAPA) processes, and collaborate closely with product development and manufacturing teams to ensure regulatory compliance. They are often involved in the review of documentation, facilitation of risk assessments, and addressing nonconformances that arise during production or post-market surveillance. Daily work may also include preparing for and participating in regulatory inspections, training staff on quality procedures, and maintaining up-to-date knowledge of relevant standards. This role is both detail-oriented and collaborative, playing a vital part in ensuring product quality and regulatory adherence.

What are the key skills and qualifications needed to thrive in medical device quality assurance?

To thrive as a Medical Device Quality Assurance professional, you need a strong background in quality systems, regulatory compliance, and risk management, often supported by a science or engineering degree and relevant work experience. Familiarity with ISO 13485, FDA 21 CFR Part 820, CAPA systems, and quality management software is typically required, along with certifications such as ASQ Certified Quality Auditor (CQA) being advantageous. Exceptional attention to detail, strong analytical thinking, and effective communication help distinguish top performers in this field. Mastery of these skills and tools ensures that medical devices consistently meet strict regulatory standards, supporting patient safety and organizational reputation.

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What are the most commonly searched types of Medical Device Quality Assurance jobs?

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Medical Device Quality Assurance jobs near you
Infographic showing various Medical Device Quality Assurance job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $60,925 per year, or $29.3 per hour.

QA/RA Consultant

Ketryx

Boston, MA • On-site, Remote

$130K - $150K/yr

Full-time

Re-posted 11 days ago

Job description

Job Title: QA/RA Consultant
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)

As a Ketryx QA/RA Consultant, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world's most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform.

Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices.

This position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). 

About You:

You're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining.

Responsibilities:
  • Lead Quality Management System (QMS) setup and deployment for medical device clients.
  • Own and manage QMS templates and regulatory compliance frameworks.
  • Provide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards.
  • Scale operations to support high-growth clients.
  • Develop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.
  • Shape the future of regulatory affairs through innovative product development.
  • Work independently on complex quality assurance projects requiring minimal oversight.
  • Ensure customer success across the entire customer engagement lifecycle.
Required Skills:
  • 4-8 years of experience in quality systems management, management representative or senior specialist role.
  • Familiar with eQMS implementation, validation and implementation.
  • Deep expertise in Quality Management System setup, sub-systems, and implementation.
  • Strong knowledge of ISO 13485 and Global QMS requirements.
  • Expertise in AI, Digital, and Cyber Compliance.
  • Deep understanding of medical device cybersecurity.
  • Experience as quality management representative in regulated environments.
  • Experience with regulatory and Notified Body submission requirements.
  • Background in medical device industry quality systems.
  • Ability to work independently and own complex regulatory projects.
  • Proven track record in consulting or client-facing roles.
Preferred Skills:
  • Experience at large medical device companies (Stryker, Medtronic, Boston Scientific).
  • Background with consulting firms specializing in QMS setup.
  • Startup experience (Series A/B) with QMS implementation.
  • Specializations in cybersecurity, usability, or computer software validation.
  • Experience scaling quality operations in high-growth environments.
  • Knowledge of AI applications in regulatory affairs.
  • Submission experience.
  • Experience working in an early stage, product-based start up.

Keywords: ISO 13485, MDSAP, Quality Management System (QMS), Management representative, Medical device quality, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Boston/Massachusetts, Consulting firms, Quality assurance, Medical device industry

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