ZipRecruiter

Log In

1

Fda Quality Reviewer Jobs (NOW HIRING)

Labor Solutions, LLC

Be Seen First

Quality Technician

Milwaukee, WI · On-site

$24 - $26/hr

... Review Board (MRB) as needed. * Maintain inspection records within the Quality Management System (QMS). * Follow ISO 13485, FDA 21 CFR Part 820, and other applicable quality standards. * Collect ...

Flotec

Be Seen First

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

Develop, review, and maintain quality procedures, work instructions, inspection plans, forms, and ... Working knowledge of ISO 13485 and FDA medical device quality system requirements. * Experience ...

Lancesoft

Quality Engineer I

Centennial, CO · On-site

$55 - $62.50/hr

Review engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T ... Understanding of FDA Quality System Regulations, ISO 13485 requirements, and other applicable ...

Balda C Brewer

Quality Engineer

Ontario, CA · On-site

$80K - $120K/yr

Participate in Material Review Board and/or Change Control Board as QA representative. * Utilize ... Working in a medical device or other FDA regulated industry. Comprehensive understanding of ISO ...

Medtronic

Sr Design Quality Engineer

Lafayette, CO

$92K - $124K/yr

Critically review new and modified product designs to evaluate impact on product requirements ... Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System ...

Iridex Corporation

Quality Engineer

Mountain View, CA · On-site

$112K - $120K/yr

... FDA and ISO 13485 requirements. This position works cross-functionally with Manufacturing ... Review and approve Engineering Change Orders (ECOs) for quality and regulatory impact. * Support ...

Medtronic

Sr Design Quality Engineer

Lafayette, CO · On-site

$92K - $124K/yr

Critically review new and modified product designs to evaluate impact on product requirements ... Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System ...

aspensurgical

Quality Engineer (NY)

Jamaica, NY

$75K - $97K/yr

Perform batch record review, deviations, nonconforming material investigations, and process ... Lead and/or participate in complaint investigations in accordance with FDA QSR, ISO 13485, and ...

Iridex Corporation

Quality Engineer

Mountain View, CA

$112K - $120K/yr

... FDA and ISO 13485 requirements. This position works cross-functionally with Manufacturing ... Review and approve Engineering Change Orders (ECOs) for quality and regulatory impact. * Support ...

Medtronic

Sr Design Quality Engineer

Lafayette, CO · On-site

$92K - $124K/yr

Critically review new and modified product designs to evaluate impact on product requirements ... Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System ...

Iridex Corporation

Quality Engineer

Mountain View, CA · On-site

$112K - $120K/yr

... FDA and ISO 13485 requirements. This position works cross-functionally with Manufacturing ... Review and approve Engineering Change Orders (ECOs) for quality and regulatory impact. * Support ...

Tempus

Author and review software validation deliverables, including Risk Assessments, Validation Plans ... FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ years experience in Computer ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site

Author and review software validation deliverables, including Risk Assessments, Validation Plans ... FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ years experience in Computer ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

Author and review software validation deliverables, including Risk Assessments, Validation Plans ... FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ years experience in Computer ...

Spectrum Staffing Services

Be Seen First

Quality Engineer

Raleigh, NC · On-site

$43 - $45/hr

Support, maintain, and improve the Quality Management System (QMS) in compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory standards. * Develop, review, and maintain quality ...

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Author and review software validation deliverables, including Risk Assessments, Validation Plans ... FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ years experience in Computer ...

Synkriom

Be Seen First

Senior Quality Engineer

Englewood, CO · On-site

$55 - $59/hr

... Review engineering drawings, specifications, and Geometric Dimensioning and Tolerancing (GD&T ... FDA Quality System Regulations, ISO 13485 requirements, and other applicable quality standards ...

next page

Showing results 1-20

All JobsFda Quality Reviewer Jobs

Fda Quality Reviewer information

See salary details

$17

$33

$85

How much do fda quality reviewer jobs pay per hour?

As of Jul 15, 2026, the average hourly pay for fda quality reviewer in the United States is $33.91, according to ZipRecruiter salary data. Most workers in this role earn between $19.71 and $39.90 per hour, depending on experience, location, and employer.

What are some common challenges faced by FDA Quality Reviewers when evaluating regulatory submissions?

FDA Quality Reviewers often face the challenge of interpreting complex scientific data within tight regulatory timelines. Ensuring that submissions meet all technical and compliance standards while coordinating with cross-functional teams, such as scientists and regulatory affairs specialists, can be demanding. Additionally, reviewers must stay up-to-date with evolving regulations and guidance documents to provide accurate and consistent feedback. Strong attention to detail and effective communication skills are essential to address these challenges successfully.

What is the difference between Fda Quality Reviewer vs Fda Compliance Specialist?

AspectFda Quality ReviewerFda Compliance Specialist
Required CredentialsTypically a degree in life sciences, quality assurance, or related field; certifications like CQE may be preferredSimilar credentials, often with additional compliance or regulatory certifications
Work EnvironmentReviewing manufacturing processes, quality documentation, and ensuring compliance with FDA standardsMonitoring regulatory adherence, conducting audits, and implementing compliance programs
Employer & Industry UsagePharmaceutical, biotech, and medical device companiesRegulatory agencies, pharmaceutical firms, and medical device manufacturers

The Fda Quality Reviewer primarily focuses on evaluating quality documentation and manufacturing processes to ensure FDA compliance. In contrast, the Fda Compliance Specialist often oversees broader regulatory adherence, conducts audits, and implements compliance strategies. Both roles require similar credentials and work within regulated industries, but their specific responsibilities differ slightly based on focus areas.

What are the key skills and qualifications needed to thrive as an FDA Quality Reviewer, and why are they important?

To thrive as an FDA Quality Reviewer, you need a robust background in life sciences, regulatory affairs, and quality assurance, often supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, Good Manufacturing Practices (GMP), and FDA guidelines, as well as certifications like RAC (Regulatory Affairs Certification), are typically required. Attention to detail, critical thinking, and effective written communication are essential soft skills for assessing documentation and communicating findings. These skills ensure that regulatory reviews are thorough, compliant, and support public health by maintaining high standards for product safety and efficacy.

What are FDA Quality Reviewers?

FDA Quality Reviewers are professionals who evaluate the quality, safety, and efficacy of products regulated by the U.S. Food and Drug Administration, such as pharmaceuticals, medical devices, and biologics. They review submitted documentation and data to ensure compliance with regulatory standards and guidelines. Their work is essential in determining whether a product can move forward in the approval process and ultimately be marketed to the public. FDA Quality Reviewers also communicate with manufacturers to request clarifications or additional information, ensuring that all products meet the necessary requirements before reaching consumers.
More about Fda Quality Reviewer jobs
What job categories do people searching Fda Quality Reviewer jobs look for? The top searched job categories for Fda Quality Reviewer jobs are:
Fda Quality Reviewer jobs near you
Infographic showing various Fda Quality Reviewer job openings in the United States as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $70,532 per year, or $33.9 per hour.
Quality Engineer

Quality Engineer

NextPhase Medical Devices LLC

Mansfield, MA • On-site

$90K - $125K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 11 days ago

Job description

Job Summary and Objectives:

The Quality Engineer will support the Quality Management System (QMS) to ensure compliance to FDA Quality System Regulation, ISO 13485 and other relevant Quality System Standards. The Quality Engineer will also participate in product development teams to provide design control quality assurance support to medical device development and validation efforts.

Essential Duties and Responsibilities:

  • Understand and ensure compliance to ISO 13485, 21 CFR Part 820 and NextPhase Quality System requirements.
  • Support audits performed by Notified Bodies and regulatory agencies as well as audits performed by customers.
  • Perform/participate in audits of NextPhase suppliers as required.
  • Act as the NextPhase quality interface for assigned customers and/or suppliers.
  • Participate in the technical review of design input specifications and design documentation for new medical devices.
  • Assist in the planning, development and execution of verification and validation protocols for testing of products under development.
  • Conduct risk analysis for products under development and for active products as required by the customer.
  • Create Quality Plans and Master Validation Plans in support of customer product implementation.
  • Support existing product/process issues, including NCRs, MRB, root cause analysis, Deviations, customer complaints, failure investigations and corrective actions.
  • Manage customer deliverables and quality documents to an approved/released state.
  • Perform such other functions, responsibilities, tasks and/or projects that are reasonably related to the above essential job functions and responsibilities and/or as NextPhase Medical Devices LLC may from time-to-time assign to the employee.

Minimum Required Education and Experience:

  • Bachelor’s Degree in Engineering, Quality Assurance or related experience.
  • 5+ years in medical device quality assurance.
  • Working understanding of ISO 13485 and FDA regulations, including QMS requirements for Class I, II and III medical devices.
  • In-depth understanding of ISO 14971 Risk Management.

Skills

  • Proficient in using quality management software, statistical analysis tools and Microsoft Office Suite.
  • Ability to conduct Root Cause Analysis using Fishbone Diagrams, 5 Whys or other analysis tools.
  • Strong written and verbal communication skills.
  • Take responsibility for task and time management.

Education and Experience:

  • 5+ years in medical device quality assurance.
  • ASQ Certification (e.g CQE, CQA) desirable.


Benefits Offered:

  • Medical, Dental, Vision Insurance
  • 401(k)
  • Paid Time Off
  • Long-Term & Short-Term Disability
  • Life Insurance
  • 10 Paid Holidays
  • Additional Voluntary Benefits

8:00am - 5:00pm