ZipRecruiter

Log In

1

Fda Quality Reviewer Jobs (NOW HIRING)

Talentrupt

Quality Systems Specialist

Fridley, MN · On-site

... FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation ... Review and approve training plans associated with change orders to ensure training requirements are ...

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 ...

Arch-Medical-Solutions

Regulatory Quality Engineer

Kenosha, WI · On-site

$69K - $90K/yr

Ensures FDA registrations and device listings are current. * Participates and supports the ECO ... For further information, please review the Know Your Rights notice from the Department of Labor. #J ...

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 ...

Abbott

Quality Engineer I

Temecula, CA · On-site

$71K - $92K/yr

... review, and maintenance of quality documentation, procedures, protocols, reports, and technical assessments. * Support compliance with cGMP requirements, Good Documentation Practices (GDP), FDA ...

AMETEK, Inc.

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 ...

Femasys Inc.

Quality Assurance Specialist

Suwanee, GA · On-site

Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and other applicable regulatory requirements. * Prepare, review, and maintain quality procedures, work instructions ...

Femasys, Inc.

Quality Assurance Specialist

Suwanee, GA · On-site

Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and other applicable regulatory requirements. * Prepare, review, and maintain quality procedures, work instructions ...

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.

Abbott

Quality Engineer I

Temecula, CA · On-site

$35 - $40/hr

... review, and maintenance of quality documentation, procedures, protocols, reports, and technical assessments. * Support compliance with cGMP requirements, Good Documentation Practices (GDP), FDA ...

Femasys, Inc.

Quality Assurance Specialist

Suwanee, GA · On-site

Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and other applicable regulatory requirements. * Prepare, review, and maintain quality procedures, work instructions ...

aspensurgical

Quality Manager

Jamaica, NY · On-site

... 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 ...

Extremity Care

Quality Assurance Inspector

San Diego, CA · On-site

$25.24 - $32.81/hr

Perform and document Device History record review and release of sub-assembly and finished products ... Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards ...

Extremity Care

Quality Assurance Inspector

San Diego, CA · On-site

$25.24 - $32.81/hr

Perform and document Device History record review and release of sub-assembly and finished products ... Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards ...

Extremity Care

Quality Assurance Inspector

San Diego, CA · On-site

$25.24 - $32.81/hr

Perform and document Device History record review and release of sub-assembly and finished products ... Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards ...

Gentuity

Quality Systems Manager

Sudbury, MA

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 ...

previous pagenext page

Showing results 21-40

All JobsHealthcare JobsHospital JobsClinical Research Director 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 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.

More about Fda Quality Reviewer jobs

What are popular job titles related to Fda Quality Reviewer jobs?

For Fda Quality Reviewer jobs, the most frequently searched job titles are:

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 2% As Needed, 80% Full Time, 14% Part Time, 3% Contract, and 1% Nights. Highlights an 83% Physical, 1% Hybrid, and 16% Remote job distribution, with an average salary of $70,532 per year, or $33.9 per hour.

Quality Systems Specialist

Fridley, MN • On-site

Talentrupt
See more jobs at Talentruptexternal

Other

Posted 12 days ago

Job description

Title: Prin Quality Systems Spec - Exempt
Location: Onsite 40/hrs week (Mon - Wed)
Address: Minneapolis, MN 55432
Duration: 9+ months with possible extension

HM's Top Needs:

1. Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation.

2. Strong understanding of quality systems, including CAPA, change control, training, and management review

3. Familiarity with risk management and root cause analysis tools

  • Support key Quality System processes, including Quality System Change Orders, training, CAPAs, issue escalation, internal and external audits, and data analysis.
  • Support the end-to-end CAPA process, including initiation, root cause analysis, action planning, implementation tracking, verification, and closure, to ensure timely and effective resolution of quality issues in compliance with internal procedures and regulatory requirements.
  • Review and approve training plans associated with change orders to ensure training requirements are appropriately defined, documented, and completed.
  • Support continuous improvement activities by helping to implement improvements to strengthen quality system effectiveness and efficiency.
  • Support key organizational initiatives and cross-functional priorities as needed.


Education Required: Bachelors

Years’ Experience Required: 7 years

Apply