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Freelance Quality Engineer Fda Jobs (NOW HIRING)

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

The Product Quality Engineer is responsible for providing quality engineering support to the ... Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

The Product Quality Engineer is responsible for providing quality engineering support to the ... Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.

Belcan

Quality Engineer

Cincinnati, OH · On-site

$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 ...

TRC Talent Solutions

Quality Engineer

Kennesaw, GA

$70K - $80K/yr

Ensure compliance with FDA regulations, ISO 13485, and other applicable standards. * Participate in ... quality engineering experience, preferably in the medical device industry. * Experience with ...

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

The Product Quality Engineer is responsible for providing quality engineering support to the ... Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.

Viant

Quality Engineer

Brimfield, MA · On-site

$70K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

medplast

Quality Engineer

Brimfield, MA · On-site

$70K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

CYNET SYSTEMS

Quality Engineer II

Scarborough, ME · On-site

$45/hr

Working knowledge of FDA regulations, ISO standards, and quality systems. * Proven ability to collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams. * Strong analytical ...

LotusBakeries

Quality Engineer

Mebane, NC · On-site

$62K - $80K/yr

The Quality Engineer is responsible for leading daily quality assurance activities on the ... SQF or BRC * FSMA/FDA requirements * Global Food Safety Initiative requirements * Good ...

medplast

Quality Engineer

Brimfield, MA

$70K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

Delcath Systems Inc

Quality Engineer

Queensbury, NY · On-site

$65K - $75K/yr

... FDA, ISO regulations and the Medical Device Directives/Regulations. The Quality Engineer provides QA support for the company by working with the Quality Assurance Manager to assure proper GMP ...

Balda-C-Brewer

Principal Quality Engineer

Manhattan, NY · On-site

$120 - $150/hr

The Principal Quality Engineer will serve as a subject matter expert in regulatory compliance (e.g., ISO 13485, FDA QSR), validation strategy, and supplier quality, ensuring robust risk management ...

New

medplast

Quality Engineer

Brimfield, MA

$70K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and ... Provides support to other quality engineers. * Performs other functions as required. The successful ...

LotusBakeries

Quality Engineer

Mebane, NC · On-site

$62K - $80K/yr

The Quality Engineer is responsible for leading daily quality assurance activities on the ... SQF or BRC * FSMA/FDA requirements * Global Food Safety Initiative requirements * Good ...

Balda C Brewer

Principal Quality Engineer

Ontario, CA · On-site

$120K - $150K/yr

The Principal Quality Engineer will serve as a subject matter expert in regulatory compliance (e.g., ISO 13485, FDA QSR), validation strategy, and supplier quality, ensuring robust risk management ...

Electrolit Manufacturing

Be Seen First

Quality Engineer

Waco, TX · On-site

$90K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Quality Engineer will report to the Quality Manager. This position will work with sensitive ... Ensure compliance with FDA LACF regulations (21 CFR Part 113) and related food safety requirements.

Trelleborg

NPD Quality Engineer

Delano, MN · On-site

$78K - $97K/yr

  • 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

Capstan Medical, Inc.

Santa Cruz, CA • On-site

$83K - $107K/yr

Full-time

Re-posted 25 days ago

Job description

The Product Quality Engineer is responsible for providing quality engineering support to the manufacturing line and supporting finished goods release for structural heart implant, delivery, and robotic devices.
Product and Operations Quality responsibilities include:
  • Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are met for medical devices.
  • Provide guidance on sterilization processes and validations to ensure product safety and compliance.
  • Facilitate sterilization activities including batch release, sterilization validation, and coordination with third party sterilizers.
  • Oversee packaging validation activities to ensure product integrity and stability during storage and transportation.
  • Participate in finished goods release processes, ensuring compliance with release criteria and applicable regulatory requirements.
  • Oversee product quality during all stages of production in a cleanroom manufacturing environment.
  • Lead and support investigations into nonconforming materials and products (NCRs), working closely with cross-functional teams including Manufacturing and Engineering, identifying root causes, ensuring timely resolution, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.
  • Participate in materials decision making as a member of Material Review Board
  • Collaborate with cross-functional teams, including Manufacturing and Engineering, to resolve quality issues and identify opportunities for process improvement and efficiency gains within the manufacturing environment.
  • Perform audits of manufacturing processes, including inspections, testing, and documentation, to identify areas for improvement and ensure adherence to quality standards.

Documentation and Compliance responsibilities include:
  • Maintain accurate and up-to-date documentation related to quality control processes, inspection results, metrology records, nonconformance reports, and corrective actions.
  • Ensure compliance with relevant regulatory requirements, such as FDA QSR and ISO 13485 standards.
  • Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings.

Skills:
  • Strong understanding of quality management systems.
  • Excellent problem-solving skills and ability to apply root cause analysis methodologies.
  • Detail-oriented with effective organizational and documentation skills.
  • Strong communication and collaboration skills to work cross-functionally and interact with technicians, engineers, auditors, and third parties.
  • Attention to detail, with a focus on accuracy and precision in quality-related activities.
  • Ability to work independently in a fast-paced organization with competing priorities.

Requirements:
  • Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.
  • Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices.
  • Experience working in a cleanroom manufacturing environment.
  • Experience with nonconforming material investigations and implementing effective CAPAs.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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