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Freelance Quality Engineer Fda Jobs (NOW HIRING)

Innovative Health LLC

Quality Engineer

Scottsdale, AZ · On-site

$70K - $90K/yr

The Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will ...

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 ...

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 ...

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 ...

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.

Fortive

Quality Engineer

Everett, WA · On-site

$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.

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 ...

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 ...

Flex

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 ...

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 · On-site

$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:

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All JobsQuality Engineer Fda JobsFreelance Quality Engineer Fda Jobs

Freelance Quality Engineer Fda information

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

As of Aug 13, 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.
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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

Innovative Health LLC

Scottsdale, AZ • On-site

$70K - $90K/yr

Full-time

Posted 18 days ago

Job description

The Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will have responsibility for identifying and driving improvements related to quality, compliance to regulatory requirements and business efficiencies within the Quality Organization.
  • Supports the Corrective and Preventive Actions Program by monitoring the system and completing investigations and implementing actions as applicable.
  • Supports Calibration and Preventative Maintenance systems
  • Represents and provides quality support for new product development initiatives.
  • Verifies and validates design and processes utilizing IQ, OQ, and PQ process.
  • Develops and writes test methods.
  • Creates documentation for manufacturing, quality control, and final release processes.
  • Generates formal test protocols and reports.
  • Supports continuous process improvements through detailed data analysis.
  • Provides documentation and support for the submission of FDA 510Ks.
  • Participates in risk management activities for product and process design projects including PFMEA risk assessments.
  • Reviews and approves complaint investigations.
  • Conduct data analysis using Minitab or equivalent statistical software.
  • Train manufacturing/QC personnel as needed on test methods or manufacturing processes.
  • Document test results per GDP, ISO and FDA requirements.
  • Participates in process improvement projects to reduce costs.
  • Assists with environmental monitoring of production facilities and equipment.
  • All other duties, as assigned.

Education and Qualifications:
  • Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field) and minimum of three (3) years experience.
  • Ability to work in a fast paced, collaborative team environment
  • Ability to handle multiple projects and coordinate cross functional teams
  • Ability to communicate effectively with management, peers and external vendors
  • Knowledge of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
  • Knowledge of risk management and risk analysis methods
  • Ability to write technical documents (procedures, test methods, protocols and reports)
  • Ability to conduct data analysis using Minitab
  • Ability to recommend technical solutions
  • Ability to specify requirements for products and equipment
  • Ability to train other engineers/manufacturing/QC/technicians
  • Ability to work with little supervision
  • Ability to use personal computers including software such as: Word, PowerPoint, Excel, Project and Minitab
  • Self-starter and highly motivated

Apply