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Fda Quality Reviewer Jobs (NOW HIRING)

Ignite Human Capital

Quality Director

Westborough, MA · On-site

$130K - $145K/yr

Chair Material Review Board (MRB) activities and oversee disposition of nonconforming materials ... FDA quality and compliance requirements * ITAR regulations * IPC standards (including component ...

Ignite Human Capital

Quality Director

Westborough, MA · On-site

$130K - $145K/yr

Chair Material Review Board (MRB) activities and oversee disposition of nonconforming materials ... FDA quality and compliance requirements * ITAR regulations * IPC standards (including component ...

Aspen Surgical

Quality Engineer (NY)

Queens, NY · On-site

$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 ...

Aspen Surgical

Quality Technician (2nd Shift)

Caledonia, MI · On-site

$17.25 - $23.25/hr

Maintain, review, and make updates to manufacturing and purchasing Control Plans in IFS * Maintain ... Establish, implement, and maintain the quality system in accordance with FDA Quality System ...

aspensurgical

Quality Technician (2nd Shift)

Caledonia, MI · On-site

$17.25 - $23.25/hr

Maintain, review, and make updates to manufacturing and purchasing Control Plans in IFS * Maintain ... Establish, implement, and maintain the quality system in accordance with FDA Quality System ...

Actalent

Quality Engineer

Minneapolis, MN

$43 - $53/hr

Generate, review, and maintain quality system documentation, including design history file (DHF), device master record (DMR), and engineering change documentation. * Ensure compliance with FDA ...

THINK Surgical, Inc.

Manager, Quality Assurance

Fremont, CA · On-site

$165K - $180K/yr

Ensure quality system processes are aligned with FDA (21 CFR Part 820/QMSR), ISO 13485, and other ... Support management review by providing meaningful data, trends, and recommendations. SUPERVISORY ...

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Fda Quality Reviewer information

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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 Director

Quality Director

Ignite Human Capital

Westborough, MA • On-site

$130K - $145K/yr

Full-time

Re-posted 20 days ago

Job description

We are seeking a strategic and hands-on Quality Leader to drive enterprise-wide quality excellence across complex manufacturing operations. This role is responsible for shaping quality strategy, leading continuous improvement initiatives, ensuring compliance with critical regulatory and industry standards, and building a culture of operational excellence.

The ideal leader brings a balance of executive-level strategic thinking and practical execution, with deep expertise in regulated manufacturing environments, supplier quality, process optimization, and cross-functional leadership. This is an opportunity to make a meaningful impact by elevating quality systems, improving throughput, reducing defects, and strengthening organizational performance across the business.

Key Responsibilities
  • Lead the overall quality function, including quality systems, compliance, reporting, and continuous improvement initiatives.
  • Serve as the executive quality leader for ISO-certified quality management systems, including ISO 9001, ISO 13485, AS9100, and support environmental management initiatives aligned with ISO 14001.
  • Act as Management Representative for applicable quality certifications, ensuring audit readiness and ongoing compliance.
  • Drive enterprise quality planning for products, processes, and manufacturing operations.
  • Chair Material Review Board (MRB) activities and oversee disposition of nonconforming materials.
  • Establish and monitor quality KPIs, dashboards, and performance metrics to drive measurable improvement.
  • Lead corrective and preventive action (CAPA) processes in partnership with Engineering, Manufacturing, and Operations.
  • Partner with suppliers to strengthen supplier quality standards, compliance, and performance.
  • Oversee calibration systems, preventive maintenance quality controls, and product/process quality assurance programs.
  • Champion Lean, 6S, and operational excellence initiatives to improve quality, throughput, and efficiency.
  • Develop and implement quality policies, procedures, and training programs to ensure consistent workmanship and adherence to standards.
  • Promote awareness of customer, regulatory, and quality requirements throughout the organization.
  • Ensure compliance with applicable regulatory frameworks including FDA, ITAR, IPC standards, and electronic manufacturing quality requirements.
  • Lead, mentor, and develop quality teams while influencing cross-functional stakeholders at all levels.
Ideal Background
  • Bachelor’s degree in Engineering, Quality, Manufacturing, or related technical discipline.
  • 10+ years of progressive quality leadership experience in a regulated manufacturing environment.
  • Deep experience with electronic manufacturing, aerospace, defense, medical device, or highly regulated production environments.
  • Strong knowledge of:
    • ISO 9001 / ISO 13485 / AS9100 / ISO 14001
    • FDA quality and compliance requirements
    • ITAR regulations
    • IPC standards (including component identification, workmanship, inspection standards)
    • CAPA, MRB, supplier quality, calibration systems, and process quality controls
    • Lean Manufacturing / World Class Manufacturing / continuous improvement methodologies
  • Proven ability to lead large teams and manage multiple technical initiatives simultaneously.
  • Strong executive presence, communication skills, and the ability to influence across engineering, manufacturing, operations, and executive leadership.
  • Strategic thinker with strong analytical problem-solving skills and a bias toward action.
  • Due to ITAR and / or CUI compliance, this position requires candidates to be a U.S. Citizen.

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