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Fda Quality Reviewer Jobs (NOW HIRING)

Inquis Medical, Inc.

Quality Manager

Menlo Park, CA ยท On-site

$145K - $165K/yr

Prepare and/or review FDA and other regulatory applications and documents, including Medical Device ... Manage internal quality audit program. * Manage Medical Device Reporting and complaint management ...

New

Inquis Medical, Inc.

Quality Manager

San Francisco, CA ยท On-site

$145K - $165K/yr

Prepare and/or review FDA and other regulatory applications and documents, including Medical Device ... Manage internal quality audit program. * Manage Medical Device Reporting and complaint management ...

New

Kellton Tech

Medical Device Quality Inspector

Madison, WI ยท On-site

$30/hr

... FDA regulations , and company quality system requirements . This role plays a critical part in ... Review final documentation and shipment packaging for medical devices, subassemblies, and kits ...

Collabera

Desgin Quality Engineer

Boulder, CO ยท On-site

$74K - $96K/yr

Participate in review of requirements, architecture, design, code and other work products with a ... Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive ...

Henke Sass Wolf Of America

Quality Manager

Dudley, MA ยท On-site

$110K - $130K/yr

Prepare and coordinate the annual Management Review, including quality KPIs, trends, risks, and ... Communicate and coordinate training on Quality, FDA GMP, and related requirements for manufacturing ...

New

Ametek

Senior Quality Engineer

Bridgeport, CT ยท On-site

$90K - $122K/yr

... 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 ...

SoftWave TRT

Quality Manager

Marietta, GA ยท On-site

... and FDA Quality System Regulations / QMSR. This role will own the quality system framework ... Conduct supplier quality reviews and support supplier audits * Partner with Supply Chain and ...

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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.

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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.

Quality Manager

Inquis Medical, Inc.

Menlo Park, CA โ€ข On-site

$145K - $165K/yr

Full-time

This job post hasย expired 1 day ago.ย Applications are no longer accepted.

Job description

This role is responsible for ensuring the company's quality system is and maintain compliance California FDB and US FDA QSR requirements. This position has the responsibility and authority to act independently from the rest of the organization on all matters affecting product quality and compliance. Specifically, this person may initiate action to prevent non-conformities; identify and document quality problems and initiate, recommend, provide and verify solutions to quality problems. This role may require deliverables from other departments to support FDA Quality Management System requirements; may issue Corrective/Preventive Action Requests to internal departments or suppliers as required; may initiate Supplier disqualification based on continued unsatisfactory performance.

Principal Responsibilities:

  • Establish and Maintain Quality Management System.
  • Maintain QMS Manual and associated procedures.
  • Review and interpret quality/regulatory compliance requirements and ensure that they are implemented through company policies and procedures.
  • Develop regulatory compliance and quality plans and strategies in concert with affected functional areas.
  • Prepare and/or review FDA and other regulatory applications and documents, including Medical Device License Applications and Medical Device Reports as required.
  • Review and approve all new and changed manufacturing processes to ensure compliance with requirements of FDA and FDB.
  • Provide support and guidance to biocompatibility and environmental control programs.
  • Review and approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
  • Manage Document Change Control
  • Manage supplier quality management/audit program.
  • Manage internal quality audit program.
  • Manage Medical Device Reporting and complaint management activities.
  • Develop, implement and supervise the non-conformance (NCR) and CAPA systems.
  • Initiate and Chair Material Review Board (MRB) if/as required.
  • Ensure training on all released QMS procedures and quality records is current.
  • Ensure calibration system for all inspection, production and R&D instruments is established and maintained.

Education / Experience Requirements:

  • Four-year bachelor's degree required. Desired in an engineering field
  • Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
  • Experience in medical device start-ups preferred
  • Minimum 6 years quality experience in FDA regulated medical devices or related industry
  • Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
  • Experience in medical device start-ups
  • Experience in managing sterilization controls for a Class II or Class III sterile product (EO Preferred)
  • Working knowledge of current FDA Quality Systems Regulation and equivalent international requirements for medical devices.
  • Direct, recent involvement in 510k Submissions, IDE Submission, and/or CE mark filings (Desired)
Compensation Range
$145,000—$165,000 USD

Inquis Medical is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.

Inquis Medical does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.