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Fda Quality Reviewer Jobs (NOW HIRING)

Collabera

Desgin Quality Engineer

Boulder, CO · 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 ...

Organ Recovery Systems

Quality Specialist

Itasca, IL · On-site

$60K - $80K/yr

... FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, MDSAP requirements, and ... Review Device History Records (DHRs), manufacturing records, test results, and associated quality ...

Cordica Medical

Be Seen First

Quality Technician/ Inspector

Haverhill, MA · On-site

$21 - $26/hr

Work with Quality and Engineering to ensure compliance with ISO and FDA Quality system requirements ... review and correction to ensure compliance with good documentation practices · Streamline the ...

New

Ametek

Senior Quality Engineer

Bridgeport, CT · 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 · 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 ...

Baird Consulting Group

Quality Manager

Dudley, MA · 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 ...

Frey Consulting Group

Quality Manager

Dudley, MA · 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

Softwave-Trt

Quality Manager

Marietta, GA · 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 Sep 13, 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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Fda Quality Reviewer jobs near you
Infographic showing various Fda Quality Reviewer job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 88% Physical, 1% Hybrid, and 11% Remote job distribution, with an average salary of $70,532 per year, or $33.9 per hour.

Medical Device Quality Inspector

Madison, WI • On-site

Kellton Tech
See more jobs at Kellton Techexternal

$30/hr

Contractor

Re-posted 21 days ago

Job description

Job Title: Medical Device Quality Inspector
Location: Madison, WI
Pay Rate: $30/hr.

Position Summary:

The Medical Device Quality Inspector is responsible for ensuring that all materials, processes, and packaging activities comply with current GMP standards, FDA regulations, and company quality system requirements. This role plays a critical part in maintaining product integrity, safety, and compliance within a controlled manufacturing environment.

Essential Functions:

  • Perform one or more of the following Quality Department functions:
  • Inspect raw materials to meet production requirements.
  • Conduct in-process inspections of manufacturing products and processes.
  • Review final documentation and shipment packaging for medical devices, subassemblies, and kits.
  • Assist in the Madison Manufacturing documentation control room.
  • Complete documentation of inspection activities, prepare and apply material quality status labels, and ensure proper storage and handling of products and labeling.
  • Support Quality by assisting with nonconformance investigations and preventive actions within the QA unit.
  • Conduct quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.

Minimum Requirements:

Education & Experience:

  • High School Diploma or equivalent required.
  • Minimum of 1 year of experience in a regulated manufacturing environment preferred.
  • Knowledge of FDA Quality System Regulations and ISO 13485 standards for medical device manufacturing.

Skills & Competencies:

  • Highly motivated with the ability to work independently.
  • Strong attention to detail and organizational skills.
  • Proficient in the use of computer-based systems.
  • Collaborative mindset; strong engagement both individually and within teams.
  • Excellent verbal and written communication skills.

Organizational Relationships & Scope:

  • Reports to the Quality Control Manager.
  • Responsible for timely completion of investigative work and detailed reporting.
  • Collaborates cross-functionally with Manufacturing, Engineering, and Quality teams to assess nonconforming products and support supplier quality efforts.

Working Conditions:

  • Work performed in a medical device manufacturing facility under controlled environmental conditions.
  • Regular exposure to cleanroom or production environments following standard safety and quality protocols.