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Medical Device Qa 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 ...

Ketryx

QA/RA Consultant

Boston, MA · On-site

$130K - $150K/yr

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 ...

6AM City

Medical Device Quality Inspector

Boston, MA · On-site

The successful candidate will use inspection tools, collaborate with cross-functional teams, and contribute to ongoing quality improvements in a medical device manufacturing environment. #J-18808 ...

New

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 ...

6AM City

Medical Device Quality Inspector

Boston, MA · On-site

The successful candidate will use inspection tools, collaborate with cross-functional teams, and contribute to ongoing quality improvements in a medical device manufacturing environment. #J-18808 ...

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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Showing results 21-40

All JobsMedical Device Qa Jobs

Medical Device Qa information

See salary details

$12

$36

$70

How much do medical device qa jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for medical device qa in the United States is $36.79, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $50.00 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a medical device QA, and why are they important?

To thrive as a Medical Device QA, you need a solid understanding of quality assurance principles, regulatory standards (such as ISO 13485 and FDA 21 CFR Part 820), and a relevant degree in engineering or life sciences. Familiarity with quality management systems (QMS), document control software, and auditing tools is typically required, along with certifications like Certified Quality Auditor (CQA) or Six Sigma. Strong attention to detail, problem-solving abilities, and effective communication help ensure compliance and drive continuous improvement. These skills and qualities are crucial to maintaining product safety, regulatory compliance, and overall quality within the highly regulated medical device industry.

What are some common challenges faced by medical device QA professionals, and how can they be addressed?

Medical Device QA professionals often encounter challenges such as navigating complex regulatory requirements, ensuring product consistency, and keeping up with frequent changes in standards. Addressing these challenges typically involves staying current with FDA and ISO updates, maintaining robust documentation practices, and fostering clear communication with cross-functional teams like R&D and manufacturing. Regular training sessions and proactive risk management strategies also help QA professionals ensure quality and compliance throughout the product lifecycle.

What is a medical device QA?

Medical Device Quality Assurance (QA) professionals are responsible for ensuring that medical devices meet regulatory standards and are safe and effective for use. They develop and implement quality management systems, conduct audits, and oversee documentation throughout the product lifecycle. QA professionals also work closely with engineering, manufacturing, and regulatory teams to identify and resolve quality issues, manage risk, and ensure compliance with industry standards such as ISO 13485 and FDA regulations.

What is the difference between Medical Device Qa vs Medical Device Quality Inspector?

AspectMedical Device QaMedical Device Quality Inspector
CertificationsISO 13485, FDA regulations, Six SigmaISO 13485, FDA regulations, Six Sigma
Work EnvironmentDesign, development, and process oversight in manufacturingInspection and testing on production lines
ResponsibilitiesEnsuring quality systems and complianceInspecting products for defects and conformance

Medical Device Qa professionals focus on quality assurance processes, compliance, and system improvements, while Medical Device Quality Inspectors primarily perform product inspections and defect detection. Both roles require similar certifications and work within the medical device industry, but their daily tasks and focus areas differ significantly.

More about Medical Device Qa jobs
What cities are hiring for Medical Device Qa jobs? Cities with the most Medical Device Qa job openings:
What states have the most Medical Device Qa jobs? States with the most job openings for Medical Device Qa jobs include:
What job categories do people searching Medical Device Qa jobs look for? The top searched job categories for Medical Device Qa jobs are:
Medical Device Qa jobs near you
Infographic showing various Medical Device Qa job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $76,520 per year, or $36.8 per hour.

QA/RA Consultant

Ketryx

Boston, MA • On-site, Remote

$130K - $150K/yr

Full-time

Re-posted 3 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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