Massachusetts Job Summary We are seeking an experienced Supplier Quality Engineer to support FDA remediation activities within a leading Medical Device organization. The ideal candidate will have ...
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Massachusetts Job Summary We are seeking an experienced Supplier Quality Engineer to support FDA remediation activities within a leading Medical Device organization. The ideal candidate will have ...
Quick apply
Massachusetts Job Summary We are seeking an experienced Supplier Quality Engineer to support FDA remediation activities within a leading Medical Device organization. The ideal candidate will have ...
Irvine, CA · On-site
$122K - $134K/yr
Quality Engineer, Staff (Software) Department: Quality Reports to: Quality, Senior Manager ... Support FDA and EU MDR submission readiness, including preparation of objective evidence, audit ...
Irvine, CA · On-site
$122K - $134K/yr
Quality Engineer, Staff (Software) Department: Quality Reports to: Quality, Senior Manager ... Support FDA and EU MDR submission readiness, including preparation of objective evidence, audit ...
Cambridge, MA · On-site
$78K - $101K/yr
Quality Engineer Location: Cambridge , MA Industry: Medical Device / Pharmaceutical Job Summary We ... Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO ...
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Cambridge, MA · On-site
$78K - $101K/yr
Quality Engineer Location: Cambridge , MA Industry: Medical Device / Pharmaceutical Job Summary We ... Support Quality Management System (QMS) activities and ensure compliance with FDA, cGMP, and ISO ...
$66K - $85K/yr
Maintain complete and accurate CAPA documentation in accordance with ISO standards, FDA Quality System Regulations (QSR), and internal quality system requirements. * Interpret engineering drawings ...
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$66K - $85K/yr
Maintain complete and accurate CAPA documentation in accordance with ISO standards, FDA Quality System Regulations (QSR), and internal quality system requirements. * Interpret engineering drawings ...
Austin, TX · Hybrid
$71K - $92K/yr
Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA * Participate in the ... flexible and collaborate on multiple projects
Austin, TX · Hybrid
$71K - $92K/yr
Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA * Participate in the ... flexible and collaborate on multiple projects
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Olive Branch, MS · On-site
$85K - $100K/yr
Quality Engineer - Medical Device Manufacturing Location: Olive Branch, MS Job Type: Full-Time Join ... Maintain documentation in compliance with ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 1271, and ...
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Olive Branch, MS · On-site
$85K - $100K/yr
Quality Engineer - Medical Device Manufacturing Location: Olive Branch, MS Job Type: Full-Time Join ... Maintain documentation in compliance with ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 1271, and ...
Newark, NJ · On-site
$75K - $97K/yr
Quality Engineer Location: New Jersey Duration: Long Term Position Overview We are seeking an ... This role will focus on ensuring compliance with FDA regulations, cGMP requirements, quality system ...
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Newark, NJ · On-site
$75K - $97K/yr
Quality Engineer Location: New Jersey Duration: Long Term Position Overview We are seeking an ... This role will focus on ensuring compliance with FDA regulations, cGMP requirements, quality system ...
We are actively hiring "Supplier Quality Engineers" (SQEs) to support a high-priority FDA Remediation Project following an FDA Warning Letter. This opportunity is ideal for professionals with strong ...
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We are actively hiring "Supplier Quality Engineers" (SQEs) to support a high-priority FDA Remediation Project following an FDA Warning Letter. This opportunity is ideal for professionals with strong ...
$30 - $38/hr
The Quality Engineer I will be responsible for supporting and improving Quality Management System ... Maintain compliance with FDA Quality System Regulation, cGMP requirements, ISO 13485, ISO 9001, and ...
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$30 - $38/hr
The Quality Engineer I will be responsible for supporting and improving Quality Management System ... Maintain compliance with FDA Quality System Regulation, cGMP requirements, ISO 13485, ISO 9001, and ...
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Avon, IN · On-site
$70K - $90K/yr
Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based ... Support and maintain compliance with ISO 13485, FDA QSR, and applicable medical device regulatory ...
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Avon, IN · On-site
$70K - $90K/yr
Quality Engineer - Medical Device Manufacturing Company Overview Flotec is an Indianapolis-based ... Support and maintain compliance with ISO 13485, FDA QSR, and applicable medical device regulatory ...
$85K - $103K/yr
Quality Engineer Santa Rosa, CA Full-Time | Direct Hire Salary: $85,000 - $103,000 per year DOE Are ... Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and quality management systems. * Experience ...
$85K - $103K/yr
Quality Engineer Santa Rosa, CA Full-Time | Direct Hire Salary: $85,000 - $103,000 per year DOE Are ... Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and quality management systems. * Experience ...
Pleasanton, CA · On-site
$34.50/hr
Position Details: Quality Engineer - Pleasanton, CA Location : Pleasanton, CA 94588 Project ... S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO ...
Pleasanton, CA · On-site
$34.50/hr
Position Details: Quality Engineer - Pleasanton, CA Location : Pleasanton, CA 94588 Project ... S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO ...
West Valley City, UT · On-site
$69K - $89K/yr
Quality Engineer Location : West Valley City, UT Duration : Long Term Position Overview We are ... FDA Quality System Regulations and internal quality procedures. • Contribute to continuous ...
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West Valley City, UT · On-site
$69K - $89K/yr
Quality Engineer Location : West Valley City, UT Duration : Long Term Position Overview We are ... FDA Quality System Regulations and internal quality procedures. • Contribute to continuous ...
West Valley City, UT · On-site
$69K - $89K/yr
Quality Engineer Location: West Valley City, UT (100% Onsite) Duration: 12+ Months Position ... Support New Product Development (NPD) and Design Quality activities in compliance with FDA 21 CFR ...
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West Valley City, UT · On-site
$69K - $89K/yr
Quality Engineer Location: West Valley City, UT (100% Onsite) Duration: 12+ Months Position ... Support New Product Development (NPD) and Design Quality activities in compliance with FDA 21 CFR ...
Mountain View, CA · On-site
$112K - $120K/yr
Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...
Mountain View, CA · On-site
$112K - $120K/yr
Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...
$112K - $120K/yr
Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...
Quick apply
$112K - $120K/yr
Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...
Mountain View, CA · On-site
$112K - $120K/yr
Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...
Quick apply
Mountain View, CA · On-site
$112K - $120K/yr
Strong working knowledge of FDA 21 CFR 820, ISO 13485, MDSAP, MDR and ISO 14971, and applicable ... ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred. * Strong problem ...
Minneapolis, MN · On-site
$88K - $132K/yr
Provide quality engineering support to US Operations to ensure FDA/ISO compliance and act as first ... Generous paid time off, flexible work hours, and flexible work arrangement options to help you ...
Minneapolis, MN · On-site
$88K - $132K/yr
Provide quality engineering support to US Operations to ensure FDA/ISO compliance and act as first ... Generous paid time off, flexible work hours, and flexible work arrangement options to help you ...
West Warwick, RI · On-site
$69K - $90K/yr
Job Title: Quality Engineer Reports to: Quality Operations Manager Job Function: The Quality ... Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and ...
West Warwick, RI · On-site
$69K - $90K/yr
Job Title: Quality Engineer Reports to: Quality Operations Manager Job Function: The Quality ... Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and ...
West Warwick, RI · On-site
$69K - $90K/yr
Job Title: Quality Engineer Reports to: Quality Operations Manager Job Function: The Quality ... Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and ...
West Warwick, RI · On-site
$69K - $90K/yr
Job Title: Quality Engineer Reports to: Quality Operations Manager Job Function: The Quality ... Support and maintain site quality systems in compliance with regulatory (ISO, GMP, FDA, etc.) and ...
$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
| Aspect | Flexible Quality Engineer Fda | Quality Assurance Specialist |
|---|---|---|
| Certifications | ISO, FDA regulations, Six Sigma | ISO, FDA regulations, Six Sigma |
| Work Environment | Manufacturing, biotech, medical devices | Manufacturing, biotech, medical devices |
| Primary Focus | Design, development, and compliance of products | Monitoring, auditing, and ensuring quality standards |
The Flexible Quality Engineer Fda and Quality Assurance Specialist roles share similar certifications and work environments, often within manufacturing and medical device industries. The main difference lies in their focus: the Flexible Quality Engineer Fda is involved in product design and compliance, while the Quality Assurance Specialist concentrates on monitoring and maintaining quality standards throughout production.
Dear Job Seeker,
I hope you're doing well.
My name is Abida Khan, Technical Recruiter at Intellectt Inc. I am reaching out regarding an exciting opportunity for a Supplier Quality Engineer position with one of our prestigious Medical Device clients
We are seeking professionals with experience in Supplier Quality Engineering, FDA Remediation, CAPA, Root Cause Analysis, DFMEA/PFMEA, Supplier Controls, Risk Management, and Medical Device Quality Systems.
I would love to connect and discuss this opportunity in more detail. If you are interested, please share your updated resume at abida.khan@intellectt.com.
I look forward to hearing from you
Job Title: Supplier Quality Engineer
Locations: Massachusetts
Job Summary
We are seeking an experienced Supplier Quality Engineer to support FDA remediation activities within a leading Medical Device organization. The ideal candidate will have strong experience in supplier quality, CAPA investigations, risk management, FMEA, supplier controls, and FDA compliance.
Core Responsibilities
• Assess supplier risk and implement supplier quality improvements.
• Review and align DFMEA, PFMEA, and supplier manufacturing processes.
• Support FDA remediation and Warning Letter activities.
• Conduct supplier quality investigations and CAPA activities.
• Support IQ/OQ/PQ validation activities.
• Collaborate with suppliers to improve process capability and quality controls.
Required Qualifications
• 5+ years of Supplier Quality Engineering experience.
• Medical Device industry experience.
• FDA remediation or Warning Letter remediation experience.
• CAPA, Root Cause Analysis, FMEA, and Supplier Quality experience.
Sourced by ZipRecruiter
51 - 200 Employees
Iselin, NJ, US
2018