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Fda Quality Reviewer Jobs (NOW HIRING)

Labor Solutions, LLC

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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

... 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 ...

Flotec

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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 ...

Labor Solutions, LLC

Quality Technician

Milwaukee, WI · On-site

$17.75 - $23.75/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 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 ...

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 ...

TEI BIOSCIENCES INC

Engineer II, Quality

Braintree, MA · On-site

$71K/yr

Review and approve quality records within established authority, including deviations, change ... Experience applying FDA and ISO quality standards within a regulated medical device environment

Integra LifeSciences

Engineer II, Quality

Braintree, MA · On-site

$73K - $94K/yr

Review and approve quality records within established authority, including deviations, change ... Experience applying FDA and ISO quality standards within a regulated medical device environment.

Integra-Lifesciences

Engineer II, Quality

Braintree, MA · On-site

$71K - $97K/yr

Review and approve quality records within established authority, including deviations, change ... Experience applying FDA and ISO quality standards within a regulated medical device environment

Integra LifeSciences

Engineer II, Quality

Braintree, MA

$73K - $94K/yr

Review and approve quality records within established authority, including deviations, change ... Experience applying FDA and ISO quality standards within a regulated medical device environment.

Integra LifeSciences Corporation

$71K/yr

Review and approve quality records within established authority, including deviations, change ... Experience applying FDA and ISO quality standards within a regulated medical device environment

Drive Medical

Quality Technician

Lehigh Acres, FL · On-site

$16.25 - $21.75/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 ...

aspensurgical

Quality Engineer (NY)

Jamaica, 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 ...

Medtronic

Sr Design Quality Engineer

Lafayette, CO · On-site

$92K - $124K/yr

Critically review new and modified product designs to evaluate impact on product requirements ... Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System ...

Medtronic

Sr Design Quality Engineer

Lafayette, CO · On-site

$92K - $124K/yr

Critically review new and modified product designs to evaluate impact on product requirements ... Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System ...

Labor Solutions, LLC

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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 ...

Glaukos Corporation

Travel periodically to supplier locations for audits, assessments, and business reviews. What We're ... Working knowledge of FDA Quality System Regulations, GMP, ISO 13485, CAPA, nonconformance ...

Becton, Dickinson and Company

Quality Engineer

El Paso, TX · On-site

$65K - $84K/yr

Develop, review, and approve quality documentation, including procedures, work instructions ... Support regulatory submissions, FDA inspections, notified body audits, and other regulatory ...

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Fda Quality Reviewer information

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$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 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.

Quality Technician

Milwaukee, WI • On-site

Labor Solutions, LLC
See more jobs at Labor Solutions, LLCexternal

$24 - $26/hr

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 18 days ago

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Job description

Quality Technician (Level 1)
Full-Time | Quality Assurance | Manufacturing

Under the direction of the Quality Supervisor, the Quality Technician Level 1 performs inspections on incoming materials using basic measurement tools and ensures accurate documentation in accordance with Good Documentation Practices (GDP). This role supports senior quality staff with final inspections, product release documentation, and compliance with ISO and FDA quality standards.


Key Responsibilities


  • Inspect incoming materials and components using calipers, micrometers, height gauges, and other measuring tools.
  • Accurately record inspection results following Good Documentation Practices (GDP).
  • Assist senior technicians and supervisors with final inspection tasks, including visual inspections and label verification.
  • Support product release documentation and batch record sign-offs.
  • Understand the role of dimensional inspection data in PPAP and First Article Inspection (FAI) submissions.
  • Retrieve engineering drawings and design records; verify revision levels for inspection reference.
  • Maintain tool usage logs and properly store measuring equipment to prevent damage.
  • Verify calibration status before use and report damaged or out-of-calibration tools.
  • Identify obvious non-conforming materials or parts and escalate issues appropriately.
  • Provide lot numbers, measurement results, and inspection details to the Material 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 dimensional data under supervision to support PPAP submissions.


Qualifications


Education

  • High school diploma or equivalent required.

Experience & Skills

  • Blueprint reading experience required.
  • Experience using calipers, micrometers, gauges, and other measurement tools required.
  • Understanding of GD&T preferred.
  • Basic Quality Assurance certifications preferred.
  • Strong attention to detail and documentation accuracy.
  • Ability to follow procedures and work effectively in a team environment.

Physical Requirements

  • Frequent standing, sitting, reading, measuring, and close-vision work.
  • Occasional lifting up to 30 lbs.
  • Intermittent lifting up to 50 lbs., reaching, kneeling, pushing, and pulling.
  • Repetitive hand movements and grasping may be required.

Work Environment

  • Primarily climate-controlled facility.
  • Some time spent on the production floor with moderate noise levels.


Company Description

Labor Solutions, LLC is a leader in the professional, temporary, and direct hire industry throughout the Midwest area. Our clients range from individual entrepreneurs to large corporations, and while we are big enough to serve Fortune 100 companies, we are small enough to stay nimble in an always-changing market.

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