ZipRecruiter

Log In

1

Freelance Quality Engineer Fda Jobs (NOW HIRING)

Exalta Group

Quality Engineer

Bonita Springs, FL · On-site

$67K - $87K/yr

Experience with FDA 21 CFR Part 820/QMSR and ISO 13485. * Strong knowledge of CAPA, root cause ... ASQ Certified Quality Engineer (CQE) * Six Sigma Green Belt or Black Belt Key Competencies

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Convergent Dental, Inc.

Quality Engineer

Waltham, MA · On-site

$90K - $135K/yr

Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and EU MDR requirements. * Demonstrated problem solving skills and the ability to analyze complex situations and make sound decisions.

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Associate's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Associate's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Associate's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Fortive

Quality Engineer

Everett, WA

$79K - $102K/yr

Description: As a Quality Engineer on our Fluke Health Solutions Quality Assurance/Regulatory ... External : Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers.

MPE-Inc

Quality Engineer

Milwaukee, WI · On-site

$74K - $95K/yr

Ensure assigned quality engineering activities comply with ISO 13485, applicable FDA/QMS requirements, customer requirements, and MPE quality system procedures. * Review drawings, specifications ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Associate's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Flex Ltd.

Quality Engineer

Manchester, CT · On-site

$72K - $93K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Job Summary The Quality Engineer will be based Manchester, CT , reporting to Quality Manager. In ... ISO13485, ISO 14971, FDA * Hands-on experience with CAPA systems, nonconformance investigations ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...

Flex

Quality Engineer

Manchester, CT

$72K - $93K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Job Summary The Quality Engineer will be based Manchester, CT , reporting to Quality Manager. In ... ISO13485, ISO 14971, FDA * Hands-on experience with CAPA systems, nonconformance investigations ...

Germfree Laboratories Inc

Quality Engineer

Ormond Beach, FL · On-site

$63K - $81K/yr

Quality Engineer · Department: Quality Engineering · Location: Ormond Beach, FL (USA) · ... Its products are engineered to support a range of customer and industry standards (cGMP / FDA 21 ...

Fortive

Quality Engineer

Everett, WA · On-site

$79K - $102K/yr

External : Industry peers, Regulatory agencies, Customers, Notified Body, FDA, Suppliers ... Strong Quality Engineering skills with working knowledge of product design verification as well as ...

Tek Labs Inc

Quality Engineer

Ohio City, OH · On-site

$67K - $87K/yr

Hiring: Quality Engineer Location: Cincinnati, OH Requirements: • Bachelor''s degree in ... FDA environments • Strong knowledge of PFMEA, DFMEA, MSA, SPC, DOE, Gage R&R, and Process ...

Comar

Quality Engineer

Buena, NJ · On-site

$71K - $92K/yr

  • Medical

  • Dental

  • Retirement

QUALITY ENGINEER At Comar, we're passionate about progress and finding opportunity in new ideas. In ... Food & Drug Administration (FDA), International Standards Organization (ISO), medical device and ...

Belcan

Quality Engineer

Cincinnati, OH

$50 - $60/hr

Quality Engineer Pay Rate: $50-60/hr Duration: 24-month contract Location: Cincinnati, OH Zip Code ... FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root ...

New

Trelleborg

NPD Quality Engineer

Delano, MN

$78K - $97K/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The NPD Quality Engineer is responsible to plan and coordinate quality engineering activities for ... ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable), EU/MDR. Responsibilities:

previous pagenext page

Showing results 21-40

All JobsQuality Engineer Fda JobsFreelance Quality Engineer Fda Jobs

Freelance Quality Engineer Fda information

See salary details

$45K

$84K

$119K

How much do freelance quality engineer fda jobs pay per year?

As of Aug 14, 2026, the average yearly pay for freelance quality engineer fda in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

What is the difference between Freelance Quality Engineer Fda vs Freelance Quality Assurance Specialist?

AspectFreelance Quality Engineer FdaFreelance Quality Assurance Specialist
CertificationsFDA regulations, ISO standards, QA certificationsISO standards, QA certifications, industry-specific credentials
Work EnvironmentMedical device, pharmaceutical, biotech industriesManufacturing, software, consumer products industries
Employer & Industry UsageRegulated industries requiring FDA complianceVarious industries focusing on quality processes
Common Search & Comparison IntentUnderstanding FDA-specific quality rolesComparing QA roles across industries

Freelance Quality Engineer Fda primarily focuses on ensuring compliance with FDA regulations in regulated industries like pharmaceuticals and medical devices. Freelance Quality Assurance Specialist covers broader quality assurance tasks across various sectors. While both roles require QA certifications, the FDA-specific role emphasizes regulatory knowledge, making it ideal for those targeting FDA-regulated industries.

What are some common challenges faced by freelance quality engineers working with FDA-regulated products?

Freelance Quality Engineers working in FDA-regulated environments often encounter challenges such as staying up-to-date with evolving FDA regulations, ensuring thorough documentation for audits, and quickly adapting to each client's unique quality management systems. They may also face tight project timelines and the need to communicate effectively with cross-functional teams, including regulatory, manufacturing, and R&D personnel. Building strong relationships and maintaining clear, consistent documentation are essential strategies for overcoming these challenges and delivering successful project outcomes.

What are the key skills and qualifications needed to thrive as a freelance quality engineer FDA?

To thrive as a Freelance Quality Engineer FDA, you need a solid background in quality assurance, regulatory compliance, and FDA guidelines, often supported by a degree in engineering or life sciences. Familiarity with tools such as quality management systems (QMS), CAPA software, and experience with ISO 13485 or similar certifications is crucial. Strong analytical thinking, attention to detail, and effective communication skills set top professionals apart in this field. These competencies are essential for ensuring product safety, regulatory adherence, and maintaining client trust in the highly regulated medical device and pharmaceutical industries.

What does a freelance quality engineer FDA do?

A Freelance Quality Engineer FDA is a professional who works independently to help companies comply with FDA regulations, particularly in industries like medical devices, pharmaceuticals, and biotechnology. They are responsible for ensuring that products and processes meet all quality and safety standards set by the FDA. Their tasks may include auditing, creating and reviewing documentation, implementing quality management systems, and assisting with regulatory submissions. By working on a contract basis, they provide specialized expertise to organizations that may not require a full-time quality engineer.
More about Freelance Quality Engineer Fda jobs

What cities are hiring for Freelance Quality Engineer Fda jobs?

Cities with the most Freelance Quality Engineer Fda job openings:

What are the most commonly searched types of Quality Engineer Fda jobs?

The most popular types of Quality Engineer Fda jobs are:

What states have the most Freelance Quality Engineer Fda jobs?

States with the most job openings for Freelance Quality Engineer Fda jobs include:

What job categories do people searching Freelance Quality Engineer Fda jobs look for?

The top searched job categories for Freelance Quality Engineer Fda jobs are:

Freelance Quality Engineer Fda jobs near you
Infographic showing various Freelance Quality Engineer Fda job openings in the United States as of August 2026, with employment types broken down into 74% Full Time, and 26% Contract. Highlights an 100% In-person job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Quality Engineer

Exalta Group

Bonita Springs, FL • On-site

$67K - $87K/yr

Full-time

Posted 22 days ago

Job description

Position Summary:

Reports directly to the Quality Manager, while working in close partnership with the Engineering and Operations departments to ensure seamless compliance and product quality.

Key Responsibilities:

​Participate in and support external regulatory, customer, and notified body audits (including FDA, BSI, or similar registrar audits)

Lead investigations using Root Cause Analysis (RCCA) and 8D Problem Solving to issue and manage Nonconformance Reports (NCR), Corrective Action Requests (CAR), and Corrective & Preventive Action (CAPA).

Manage Supplier Quality Management and Quality Management Systems (QMS), including Supplier Assessments, supplier performance improvement, source inspection, and product acceptance.

Analyze quality metrics, identify trends, and drive continuous improvement initiatives.

Collaborate on Cross-Functional Projects to improve product quality, process capability, and manufacturing performance.

Qualifications
  • Bachelor's degree in Engineering or related technical discipline. Experience may be considered in lieu of education for exceptional candidates
  • 3–5 years of Quality experience in medical device manufacturing.
  • Experience with FDA 21 CFR Part 820/QMSR and ISO 13485.
  • Strong knowledge of CAPA, root cause analysis, process validation, SPC, and risk management.
  • Experience in a contract manufacturing (CMO/CDMO) environment preferred.
Preferred Certifications
  • ASQ Certified Quality Engineer (CQE)
  • Six Sigma Green Belt or Black Belt
Key Competencies
  • Analytical problem-solving
  • Attention to detail
  • Strong communication and collaboration
  • Customer focus
  • Continuous improvement mindset
  • Ability to manage multiple priorities in a fast-paced manufacturing environment


Apply