North Haven, CT · On-site
$88K - $119K/yr
FDA 21 CFR Part 820 & ISO 13485 Preferred: * Medical Device Manufacturing * ISO 14971, EU MDR, Minitab * Lean Six Sigma, Supplier Quality & Audit Support Education: Bachelor's degree in Engineering ...
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North Haven, CT · On-site
$88K - $119K/yr
FDA 21 CFR Part 820 & ISO 13485 Preferred: * Medical Device Manufacturing * ISO 14971, EU MDR, Minitab * Lean Six Sigma, Supplier Quality & Audit Support Education: Bachelor's degree in Engineering ...
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.
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.
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.
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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.
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 ...
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 ...
Arroyo, PR · On-site
$69K - $89K/yr
Kelly ® Engineering is seeking Quality Engineer for contract position at manufacturing client in ... Strong knowledge of FDA regulations, ISO 13485, MDR, and other applicable standards. * Proficiency ...
Arroyo, PR · On-site
$69K - $89K/yr
Kelly ® Engineering is seeking Quality Engineer for contract position at manufacturing client in ... Strong knowledge of FDA regulations, ISO 13485, MDR, and other applicable standards. * Proficiency ...
Ensure compliance with FDA regulations , ISO 13485 , and internal Quality System requirements. * Collaborate with Manufacturing, Engineering, and Quality teams to resolve quality issues. * Support ...
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Ensure compliance with FDA regulations , ISO 13485 , and internal Quality System requirements. * Collaborate with Manufacturing, Engineering, and Quality teams to resolve quality issues. * Support ...
$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.
$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.
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 ...
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 ...
$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 ...
$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 ...
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 ...
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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 ...
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 ...
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 ...
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 ...
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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 ...
Cincinnati, OH · On-site
$69K - $89K/yr
Quality Engineer Job Summary: The Quality Engineer supports Tennant Solutions' quality management ... This role partners cross-functionally to ensure compliance with ISO 9001, ISO 13485, FDA Quality ...
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Cincinnati, OH · On-site
$69K - $89K/yr
Quality Engineer Job Summary: The Quality Engineer supports Tennant Solutions' quality management ... This role partners cross-functionally to ensure compliance with ISO 9001, ISO 13485, FDA Quality ...
$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 ...
$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 ...
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 ...
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 ...
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 ...
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 ...
Santa Clara, CA · On-site
$84K - $109K/yr
Quality Engineer III Location: Santa Clara, CA (100% Onsite) Duration: 12-month contract Shift ... Knowledge of FDA regulations, ISO 13485, and EU MDR is preferred * Experience with Power BI ...
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Santa Clara, CA · On-site
$84K - $109K/yr
Quality Engineer III Location: Santa Clara, CA (100% Onsite) Duration: 12-month contract Shift ... Knowledge of FDA regulations, ISO 13485, and EU MDR is preferred * Experience with Power BI ...
Waco, TX · On-site
$63K - $82K/yr
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.
Waco, TX · On-site
$63K - $82K/yr
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.
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Waco, TX · On-site
$90K/yr
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.
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Waco, TX · On-site
$90K/yr
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.
Fort Lauderdale, FL · On-site
$90K - $120K/yr
Quality Engineer Location: Sunrise, FL Industry: Medical Device Manufacturing Experience Level ... Ensure compliance with FDA Quality Management System Regulation (QMSR/21 CFR 820) and ISO 13485 ...
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Fort Lauderdale, FL · On-site
$90K - $120K/yr
Quality Engineer Location: Sunrise, FL Industry: Medical Device Manufacturing Experience Level ... Ensure compliance with FDA Quality Management System Regulation (QMSR/21 CFR 820) and ISO 13485 ...
$45K - $51.7K
1% of jobs
$51.7K - $58.5K
3% of jobs
$58.5K - $65.2K
7% of jobs
$65.2K - $71.9K
13% of jobs
$72.2K is the 25th percentile. Wages below this are outliers.
$71.9K - $78.6K
18% of jobs
The median wage is $81.4K / yr.
$78.6K - $85.4K
19% of jobs
$90.9K is the 75th percentile. Wages above this are outliers.
$85.4K - $92.1K
17% of jobs
$92.1K - $98.8K
9% of jobs
$98.8K - $105.5K
6% of jobs
$105.5K - $112.3K
4% of jobs
$112.3K - $119K
2% of jobs
$45K
$84K
$119K
A Quality Engineer FDA ensures that products and processes comply with FDA regulations and quality standards in industries like medical devices, pharmaceuticals, or biotech. They develop and implement quality systems, conduct audits, and support regulatory filings. Their role also includes investigating defects, implementing corrective actions, and collaborating with cross-functional teams to maintain compliance and improve quality.
A Quality Engineer FDA typically requires a background in engineering or life sciences, in-depth knowledge of FDA regulations (such as cGMP and 21 CFR Part 820), and experience with quality systems management. Familiarity with tools like CAPA (Corrective and Preventive Action), Risk Management, document control software, and certifications such as ASQ Certified Quality Engineer (CQE) are highly valued. Strong attention to detail, problem-solving skills, and the ability to communicate clearly across departments are crucial soft skills. These competencies ensure compliance with regulatory standards, reduce risk, and support the delivery of safe, effective products in regulated industries.
Quality Engineers working with FDA-regulated products often navigate complex regulatory requirements and must ensure strict adherence to quality protocols. They may face challenges such as addressing audit findings, implementing corrective actions quickly, and keeping up with evolving compliance standards. Collaboration across cross-functional teams—like manufacturing, regulatory affairs, and R&D—is vital to resolve issues and maintain consistent documentation. Successfully overcoming these challenges helps maintain product quality and reduces the risk of regulatory citations, positioning you as a valuable asset to your organization.
$88K - $119K/yr
Contractor
Posted 10 days ago
Hello,
I hope you're doing well.
My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Sr. Quality Engineer based in North Haven, CT (Onsite) with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com OR +1 (732) 737 8381
Job Title: Sr. Quality Engineer
Location: North Haven, CT (Onsite)
Job Description:
We are seeking a Sr. Quality Engineer with 4+ years of experience in medical device quality systems and regulated manufacturing. The ideal candidate will have expertise in CAPA, NCR, process validation, root cause analysis, risk management, and FDA/ISO compliance to support manufacturing quality and continuous improvement.
Required Skills:
Preferred:
Education: Bachelor's degree in Engineering or a related technical field.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381
Sourced by ZipRecruiter
51 - 200 Employees
Iselin, NJ, US
2018
