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 ...
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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 ...
Redwood City, CA · On-site
$88K - $113K/yr
Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971. 10. Working Environment: Job duties are ... ASQ Certified Quality Engineer certification preferred. Other Essential Knowledge, Skills, and ...
Redwood City, CA · On-site
$88K - $113K/yr
Working knowledge of FDA QSR, EN/ISO 13485 and EN/ISO14971. 10. Working Environment: Job duties are ... ASQ Certified Quality Engineer certification preferred. Other Essential Knowledge, Skills, and ...
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 ...
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 ...
North Haven, CT · On-site
$88K - $119K/yr
Ensure compliance with FDA, ISO 13485, and quality management system requirements. Required Qualifications * Bachelor's degree in Engineering or related technical field. * 4+ years of Quality ...
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North Haven, CT · On-site
$88K - $119K/yr
Ensure compliance with FDA, ISO 13485, and quality management system requirements. Required Qualifications * Bachelor's degree in Engineering or related technical field. * 4+ years of Quality ...
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
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
San Diego, CA · On-site
FDA & ISO 13485 Compliance * Supplier Quality Issue Resolution * Risk Assessment & Continuous Improvement * Cross-functional Collaboration with Engineering, Manufacturing & Purchasing Requirements:
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San Diego, CA · On-site
FDA & ISO 13485 Compliance * Supplier Quality Issue Resolution * Risk Assessment & Continuous Improvement * Cross-functional Collaboration with Engineering, Manufacturing & Purchasing Requirements:
$57 - $63/hr
Quality Engineer We are seeking a Quality Engineer to join a growing medical device contract ... Maintain and improve Quality Management System (QMS) processes in accordance with FDA QMSR, ISO ...
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$57 - $63/hr
Quality Engineer We are seeking a Quality Engineer to join a growing medical device contract ... Maintain and improve Quality Management System (QMS) processes in accordance with FDA QMSR, ISO ...
$68K - $88K/yr
Quality Engineer (Sterilization) The Quality Engineer plays a key role in ensuring that innovative ... Working knowledge of US FDA and international regulatory requirements for medical devices.
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$68K - $88K/yr
Quality Engineer (Sterilization) The Quality Engineer plays a key role in ensuring that innovative ... Working knowledge of US FDA and international regulatory requirements for medical devices.
Piscataway, NJ · Remote
$73K - $95K/yr
Ensure compliance with FDA, ISO 13485, and medical device quality standards. * Support risk ... Bachelor's degree in Engineering or a related field. * 5+ years of Product Quality Engineering ...
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Piscataway, NJ · Remote
$73K - $95K/yr
Ensure compliance with FDA, ISO 13485, and medical device quality standards. * Support risk ... Bachelor's degree in Engineering or a related field. * 5+ years of Product Quality Engineering ...
Marietta, OH · On-site
$56K - $73K/yr
Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...
Marietta, OH · On-site
$56K - $73K/yr
Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...
Marietta, OH · On-site
$56K - $73K/yr
Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...
Marietta, OH · On-site
$56K - $73K/yr
Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards ... Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or ...
North Haven, CT · On-site
$88K - $119K/yr
... FDA and ISO requirements. Key Responsibilities: · Support manufacturing quality and product ... Required Qualifications · Bachelor's degree in Engineering or related technical field. · 4+ years ...
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North Haven, CT · On-site
$88K - $119K/yr
... FDA and ISO requirements. Key Responsibilities: · Support manufacturing quality and product ... Required Qualifications · Bachelor's degree in Engineering or related technical field. · 4+ years ...
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 ...
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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 ...
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.
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.
Northfield, IL · On-site
$74K - $96K/yr
Ensure compliance with FDA and international quality regulations * Maintain Device Master Records ... Bachelor's degree in Engineering, Science, Mathematics, or related technical field. Thanks ...
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Northfield, IL · On-site
$74K - $96K/yr
Ensure compliance with FDA and international quality regulations * Maintain Device Master Records ... Bachelor's degree in Engineering, Science, Mathematics, or related technical field. Thanks ...
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 ...
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 ...
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 ...
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 ...
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 ...
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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 ...
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
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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
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 ...
$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.
$70K - $90K/yr
Full-time
Posted 9 days ago
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.
Education and Qualifications:
