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Fda Quality Reviewer Jobs (NOW HIRING)

Hippocratic AI

RN/NP Clinical Quality Reviewer

RN/NP Clinical Quality Reviewer Primary Care, Acute Symptom Triage & Travel Health | Contract, up ... Engagement expected to run in support of ongoing agent development and FDA evaluation milestones.

New

AMETEK, Inc.

Senior Quality Engineer

Bridgeport, CT · On-site

$90 - $115/hr

... FDA quality system regulations. You will develop and implement inspection/validation techniques ... Supports the Material Review Board (MRB) for internal non-conformances and customer returns. * May ...

Structure Medical

QUALITY INSPECTOR

Mooresville, NC · On-site

Review inspection and test data, identify deviations, and support process validation activities ... Experience in medical devices, precision machining, regulated manufacturing, ISO 13485, or FDA ...

Medtronic

Design Quality Engineer II

Lafayette, CO · On-site

Review new and modified product designs to help assess impact to product requirements, patient ... Familiarity with ISO 13485, FDA Quality System Regulation / QMSR expectations, EU MDR, or other ...

Medtronic

Design Quality Engineer II

Lafayette, CO

Review new and modified product designs to help assess impact to product requirements, patient ... Familiarity with ISO 13485, FDA Quality System Regulation / QMSR expectations, EU MDR, or other ...

aspensurgical

Quality Manager

Jamaica, NY

... Reviews of the Quality System * Carry out leadership responsibilities in accordance with the ... FDA's QMSR, ISO 13485, and other international standards) * Host FDA/ISO and other regulatory ...

Medtronic

Design Quality Engineer II

Lafayette, CO

Review new and modified product designs to help assess impact to product requirements, patient ... Familiarity with ISO 13485, FDA Quality System Regulation / QMSR expectations, EU MDR, or other ...

Labor Solutions, LLC

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 ...

Gentuity

Quality Systems Manager

Sudbury, MA · On-site

Lead Management Review and Quality Planning. Lead and manage site training program. Track and ... FDA Quality System Regulation Strong knowledge of Quality Systems programs including but not ...

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 ...

Gentuity

Quality Systems Manager

Sudbury, MA · On-site

... FDA, ISO, MDD/MDR, and individual country requirements). * Manage Document Control system ... Lead Management Review and Quality Planning. * Lead and manage site training program. * Track and ...

Drive Medical

Quality Technician

Lehigh Acres, FL · On-site

$21.60 - $25/hr

Reviews and interprets product and component drawings and supplier documentation. * Performs tasks in accordance with applicable requirements of the FDA Quality System Regulation, ISO 13485, MDD ...

Gentuity LLC

Quality Systems Manager

Sudbury, MA · On-site

$145K - $165K/yr

... FDA, ISO, MDD/MDR, and individual country requirements). • Manage Document Control system ... review of supplier data as appropriate. • Own the development of Quality Metrics, and coordinate ...

Labor Solutions, LLC

Be Seen First

2nd Shift - 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 ...

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Fda Quality Reviewer information

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How much do fda quality reviewer jobs pay per hour?

As of Aug 22, 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 is an FDA Quality Reviewer?

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.

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

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 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.

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 August 2026, with employment types broken down into 84% Full Time, 2% Part Time, and 14% Contract. Highlights an 100% In-person job distribution, with an average salary of $70,532 per year, or $33.9 per hour.

RN/NP Clinical Quality Reviewer

Hippocratic AI

Remote

Other

Posted 3 days ago

New

Job description

RN/NP Clinical Quality Reviewer

Primary Care, Acute Symptom Triage & Travel Health | Contract, up to 25 hrs/week

About the Role

We are seeking nurses and nurse practitioners with clinical experience in one or more of the following areas:

  • Telephone or virtual acute symptom triage
  • Hypertension and congestive heart failure (CHF) management
  • Medication titration for hypertension and/or CHF
  • Diabetes management and insulin titration
  • Travel health

to serve as a subject matter expert supporting the evaluation of AI-driven clinical agents. In this role, you will evaluate agent conversations and recommendations spanning acute symptom triage and escalation decisions, insulin/diabetes titration, and pre-travel health guidance, ensuring clinical accuracy, guideline adherence, and patient safety. This is a part-time, remote contract position (1099) requiring up to 25 hours per week, with flexible scheduling.

Key Responsibilities
  • Review recorded and simulated AI agent interactions involving acute symptom triage and assess the appropriateness of triage, escalation, and de-escalation decisions.
  • Evaluate AI agent conversations involving hypertension and CHF management, including medication titration, for clinical accuracy and adherence to evidence-based protocols.
  • Review agent conversations related to diabetes management and insulin titration for clinical accuracy and guideline adherence.
  • Evaluate agent-delivered travel health guidance, including pre-travel counseling, vaccination recommendations, and destination-specific risk assessment.
  • Review AI agent calls for adherence to established clinical protocols and appropriate medical management.
  • Score and annotate agent performance using structured evaluation rubrics.
  • Perform clinical data annotation by rewriting or correcting AI agent responses to align with evidence-based protocols and clinical practice guidelines.
  • Identify clinical safety concerns, inappropriate recommendations, edge cases, and gaps in agent clinical reasoning.
  • Provide clear, actionable written feedback to clinical and product teams to inform agent refinement.
  • Participate in periodic case review and calibration sessions with other clinical SMEs to ensure consistent evaluation standards.
  • Help develop and refine test scenarios used in ongoing agent quality assurance.
Qualifications
  • Registered Nurses: Active, unrestricted RN license in the United States.
  • Nurse Practitioners: Active, unrestricted NP license in the United States, with current board certification (ANCC or AANP).
  • Hands-on professional experience conducting protocol-based virtual or telephone clinical triage; and/or
  • Hands-on clinical experience directly managing patients with hypertension and/or congestive heart failure (CHF).
  • For candidates with hypertension/CHF management experience, hands-on experience prescribing, adjusting, or titrating medications for these patients.
  • Strong working knowledge of evidence-based protocols and clinical practice guidelines relevant to acute triage and/or hypertension and CHF management.
Recommended

It is not a requirement that candidates have all of the recommended criteria

  • Experience in telephone triage or nurse advice line settings.
  • Experience in travel medicine, occupational health, or pre-travel consultation.
  • Familiarity with CDC and other travel medicine guidelines.
  • Prior experience in clinical quality assurance, utilization review, or case review.
  • Familiarity with AI-assisted clinical tools or digital health platforms.
Engagement Details
  • Contract (1099) position, up to 25 hours per week.
  • Fully remote; flexible scheduling.
  • Hourly compensation, commensurate with experience.
  • Engagement expected to run in support of ongoing agent development and FDA evaluation milestones.

Please be aware of recruitment scams impersonating Hippocratic AI. All recruiting communication will come from @ hippocraticai.com email addresses. We will never request payment or sensitive personal information during the hiring process.

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