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Freelance Quality Engineer Fda Jobs in Springfield, MA

Flex Ltd.

Quality Engineer

Manchester, CT · On-site

$72K - $93K/yr

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 ...

Flex

Quality Engineer

Manchester, CT · On-site

$72K - $93K/yr

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 ...

Intellectt INC

Quality Engineer

Westfield, MA · On-site

$75K - $97K/yr

Initiate and execute quality assurance activities aligned with FDA Quality System Regulations and ... Engineering experience * Experience in medical devices (preferred) OR pharma/electronics

Viant

Quality Engineer

Brimfield, MA · On-site

$70K - $95K/yr

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

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

$70K - $95K/yr

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

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 ...

Cadence Inc

Validation Engineer II

Suffield, CT · On-site

$83K - $105K/yr

This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and manufacturing teams. Key Responsibilities:

Green Thumb

Quality Assurance Manager

Holyoke, MA · On-site

FDA cGMP competency in 21 CFR Part 111 & 117 preferred. Cannabis experience is a plus. * Bachelor ... science, Chemistry, Engineering or similar preferred * 3-5 years of progressive leadership ...

Green Thumb

Quality Assurance Manager

Holyoke, MA · On-site

FDA cGMP competency in 21 CFR Part 111 & 117 preferred. Cannabis experience is a plus. * Bachelor ... science, Chemistry, Engineering or similar preferred * 3-5 years of progressive leadership ...

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All JobsQuality Engineer Fda JobsFreelance Quality Engineer Fda JobsFreelance Quality Engineer Fda Jobs in Springfield, MA

Freelance Quality Engineer Fda information

See Springfield, MA salary details

$44.8K

$83.7K

$118.6K

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

As of Aug 6, 2026, the average yearly pay for freelance quality engineer fda in Springfield, MA is $83,745.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,700.00 and $92,700.00 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.
What are popular job titles related to Freelance Quality Engineer Fda jobs in Springfield, MA? For Freelance Quality Engineer Fda jobs in Springfield, MA, the most frequently searched job titles are:
What job categories do people searching Freelance Quality Engineer Fda jobs in Springfield, MA look for? The top searched job categories for Freelance Quality Engineer Fda jobs in Springfield, MA are:
What cities near Springfield, MA are hiring for Freelance Quality Engineer Fda jobs? Cities near Springfield, MA with the most Freelance Quality Engineer Fda job openings:
Freelance Quality Engineer Fda jobs near you

Quality Engineer

Flex Ltd.

Manchester, CT • On-site

$72K - $93K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 2 days ago

Job description

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.
Job Summary
The Quality Engineer will be based Manchester, CT, reporting to Quality Manager. In this role, you will be maintaining quality engineering programs, standards and improvements within the organization.
What a typical day looks like:
  • Develop, implement, and maintain quality standards, inspection methods, validation strategies, and testing procedures to ensure compliance with ISO 13485, FDA Quality System Regulations, GMP requirements, and customer expectations.
  • Lead quality engineering activities throughout the product lifecycle, including process and equipment validations (IQ/OQ/PQ), change assessments, product and process qualifications, and validation documentation to ensure a maintained state of control.
  • Drive risk-based decision making by applying ISO 14971 principles through PFMEAs, hazard analyses, risk assessments, and risk mitigation activities to support product quality, patient safety, and regulatory compliance.
  • Investigate nonconformances, customer complaints, returned product, and process deviations using structured problem-solving methodologies. Lead CAPA activities, root cause investigations, and continuous improvement initiatives to enhance quality performance and reduce the Cost of Poor Quality (COPQ).
  • Analyze quality data, monitor process performance, and assess equipment and measurement system capability to ensure the accuracy, reliability, and integrity of quality-related information. Consolidate and communicate quality metrics and trends to management and customers as required.
  • Partner closely with Manufacturing, Engineering, Compliance, Operations, and Program Management teams to resolve quality issues, support customer needs, and ensure successful implementation of quality and compliance objectives.
  • Support internal, customer, supplier, and regulatory audits, provide training on quality system requirements and quality control activities, and serve as a quality representative during interactions with customers and regulatory agencies.
  • Approve product, process, equipment, and validation qualifications while ensuring compliance with established quality standards, regulatory requirements, and industry best practices.

The experience we're looking to add to our team:
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, or a related technical discipline. Equivalent combination of education and relevant industry experience may be considered.
  • Minimum of 3 years of Quality Engineering experience in a manufacturing environment, preferably within highly regulated industries.
  • Minimum of 1 year of experience in the medical device industry. ISO13485, ISO 14971, FDA
  • Hands-on experience with CAPA systems, nonconformance investigations, root cause analysis, deviation management, and continuous improvement initiatives within a regulated manufacturing environment.

What you'll receive for the great work you provide:
  • Full range of medical, dental, and vision plans
  • Life Insurance
  • Short-term and Long-term Disability
  • Matching 401(k) Contributions
  • Vacation and Paid Sick Time
  • Tuition Reimbursement

Application Deadline:
Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.
Job Posting Start Date 07-16-2026 Job Posting End Date
Job Category
Quality
Is Sponsorship Available?
No
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).
Flex Personnel logo

About Flex Personnel

Sourced by ZipRecruiter

The Flex Team is made up of Staffing Industry experts committed to serving the needs of businesses and workers by bringing people together. We are guided by our Core values Integrity, Courtesy, and Respect. At Flex we bring Businesses and People together. We carefully assess both the needs of our Business clients and the complete profiles of each candidate, and then make the connections we believe will be most mutually beneficial. With offices in select markets throughout the Country, We are continually expanding our industry reach nationwide.

Industry

Recruiting and staffing services

Company size

11 - 50 Employees

Headquarters location

Dallas, TX, US

Social media

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