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Remote 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 ...

Actalent

Quality Assurance Associate

Sturtevant, WI · Remote

Provide technical support and remote troubleshooting guidance to users and customers as needed ... Evaluate complaints to determine whether submission of a Medical Device Report (MDR) or other ...

A-dec, Inc.

Quality Assurance Specialist, Sr

Newberg, OR · Remote

$86K - $119K/yr

... Medical Device regulations and standards including US-FDA, Health Canada, and the European Union ... Fully remote is not an option due to manufacturing facility-based activities. Education and ...

System One

Quality Assurance Engineer

Mahwah, NJ · Remote

$42 - $48/hr

Hybrid - onsite and remote Responsibilities * Provide quality engineering support in quality ... Firm understanding of Med Device concepts. * Familiarity with ISO 13485, GDP, GMP concepts.

Sterling Engineering, Inc.

Be Seen First

Medical Device Sales Representative

San Francisco, CA · Remote

$80K/yr

Remote (must live within territory - northern California, Oregon, or Washington) Hire Type ... Proven B2B sales experience (medical device experience preferred but not required) * Experience ...

Pavago

Quality Assurance Engineer

Quality Assurance Engineer (Manual + Automation SaaS) - Remote Position Type: Full-Time, Remote ... Cross-browser & cross-device testing * Log bugs in: * Jira * Azure DevOps * Provide: * Clear ...

Epic Kids Inc.

QA Engineer

$120K - $140K/yr

This is a fully remote, US-based role working closely with a global engineering team. Key ... device coverage on real iOS and Android devices * Own release verification -- run smoke and sanity ...

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Remote Medical Device Quality Assurance information

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

As of Jul 26, 2026, the average hourly pay for remote 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 are the key skills and qualifications needed to thrive as a Remote Medical Device Quality Assurance professional, and why are they important?

To thrive as a Remote Medical Device Quality Assurance professional, you need a solid understanding of quality management systems, regulatory compliance (such as FDA and ISO 13485), and experience in medical device manufacturing or engineering. Familiarity with tools like CAPA systems, document control software, and audit management platforms, along with relevant certifications such as CQE or RAC, is highly valuable. Strong attention to detail, analytical thinking, and effective remote communication skills help you excel in ensuring product quality and regulatory adherence. These competencies are crucial for maintaining safety standards, ensuring compliance, and supporting product integrity in a distributed work environment.

What is Remote Medical Device Quality Assurance?

Remote Medical Device Quality Assurance involves ensuring that medical devices meet regulatory and quality standards while working from a location outside of a traditional office or laboratory. Professionals in this role review documentation, conduct virtual audits, and collaborate with teams to maintain compliance with industry regulations such as FDA or ISO standards. The work helps ensure patient safety and product effectiveness, even when performed remotely, by leveraging digital tools and secure communication platforms. This role is essential for companies manufacturing medical devices, as it helps identify and mitigate risks throughout the product lifecycle.

What is the difference between Remote Medical Device Quality Assurance vs Remote Medical Device Regulatory Affairs Specialist?

AspectRemote Medical Device Quality AssuranceRemote Medical Device Regulatory Affairs Specialist
CertificationsISO 13485, FDA QSR, CAPAFDA, ISO 13485, Regulatory Affairs certifications
Work EnvironmentQuality departments, manufacturing, compliance teamsRegulatory teams, legal, compliance departments
Industry UsageEnsures product quality, compliance, auditsManages submissions, regulatory strategies, approvals
Search IntentQuality assurance roles, compliance jobsRegulatory affairs roles, submission jobs

Remote Medical Device Quality Assurance focuses on maintaining product quality, compliance, and conducting audits, while Remote Medical Device Regulatory Affairs Specialists handle regulatory submissions, approvals, and compliance strategies. Both roles are essential in the medical device industry but serve different functions within the product lifecycle.

How does a Remote Medical Device Quality Assurance professional typically collaborate with cross-functional teams to ensure compliance and product quality?

In a remote Medical Device Quality Assurance role, professionals regularly work with cross-functional teams such as engineering, regulatory affairs, and manufacturing via virtual meetings and digital collaboration tools. They participate in design reviews, risk assessments, and audits to ensure that all processes and products meet regulatory standards. Clear communication, thorough documentation, and proactive follow-up are essential to bridge the distance and keep projects on track. Adapting to virtual teamwork and leveraging technology are key to maintaining high standards in product quality and compliance.
More about Remote Medical Device Quality Assurance jobs
What cities are hiring for Remote Medical Device Quality Assurance jobs? Cities with the most Remote Medical Device Quality Assurance job openings:
What are the most commonly searched types of Medical Device Quality Assurance jobs? The most popular types of Medical Device Quality Assurance jobs are:
What states have the most Remote Medical Device Quality Assurance jobs? States with the most job openings for Remote Medical Device Quality Assurance jobs include:
What job categories do people searching Remote Medical Device Quality Assurance jobs look for? The top searched job categories for Remote Medical Device Quality Assurance jobs are:
Remote Medical Device Quality Assurance jobs near you
Infographic showing various Remote Medical Device Quality Assurance job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 89% Full Time, 8% Part Time, and 2% Contract. Highlights an 93% Physical, 3% Hybrid, and 4% Remote job distribution, with an average salary of $60,925 per year, or $29.3 per hour.
QA/RA Consultant

QA/RA Consultant

Ketryx

Boston, MA • On-site, Remote

$130K - $150K/yr

Other

Posted 16 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, Stryker, Medtronic, Boston Scientific, 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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