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 ...
$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 ...
$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 ...
$80K - $120K/yr
FDA 21 CFR Parts 11, 210/211, 820 (QMSR) * ISO 13485, ISO 9001 (as applicable) * EU MDR/IVDR and EU ... A flexible schedule and work environment built around mutual trust and accountability. Share the ...
$80K - $120K/yr
FDA 21 CFR Parts 11, 210/211, 820 (QMSR) * ISO 13485, ISO 9001 (as applicable) * EU MDR/IVDR and EU ... A flexible schedule and work environment built around mutual trust and accountability. Share the ...
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 ...
Moundsview, MN · On-site
$80K - $120K/yr
FDA 21 CFR Parts 11, 210/211, 820 (QMSR) * ISO 13485, ISO 9001 (as applicable) * EU MDR/IVDR and EU ... A flexible schedule and work environment built around mutual trust and accountability. • Share ...
Moundsview, MN · On-site
$80K - $120K/yr
FDA 21 CFR Parts 11, 210/211, 820 (QMSR) * ISO 13485, ISO 9001 (as applicable) * EU MDR/IVDR and EU ... A flexible schedule and work environment built around mutual trust and accountability. • Share ...
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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Be Seen First
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 ...
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 ...
Greer, SC · On-site
$50/hr
Quality Engineer Are you a Quality Engineer ready to take your career to new heights? We have an ... Responsible for ensuring compliance with regulatory standards (GMP, ISO, FDA) and customer ...
Greer, SC · On-site
$50/hr
Quality Engineer Are you a Quality Engineer ready to take your career to new heights? We have an ... Responsible for ensuring compliance with regulatory standards (GMP, ISO, FDA) and customer ...
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 ...
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 ...
Greer, SC · On-site
Quality Engineer Are you a Quality Engineer ready to take your career to new heights? We have an ... Responsible for ensuring compliance with regulatory standards (GMP, ISO, FDA) and customer ...
Quick apply
Greer, SC · On-site
Quality Engineer Are you a Quality Engineer ready to take your career to new heights? We have an ... Responsible for ensuring compliance with regulatory standards (GMP, ISO, FDA) and customer ...
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 ...
West Valley City, UT · On-site
$69K - $89K/yr
Quality Engineer Location : West Valley City, UT Duration : Long Term Position Overview We are ... Ensure compliance with FDA Quality System Regulations and internal quality procedures. * Contribute ...
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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 ... Ensure compliance with FDA Quality System Regulations and internal quality procedures. * Contribute ...
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 ...
Scottsdale, AZ · On-site
$72K - $93K/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
$72K - $93K/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 ...
San Diego, CA · On-site
Supplier Quality Engineer Location: Near San Diego, CA Job Summary: We are seeking a Supplier ... Support compliance with FDA 21 CFR Part 820 (QMSR) and ISO 13485 . * Prepare quality reports and ...
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San Diego, CA · On-site
Supplier Quality Engineer Location: Near San Diego, CA Job Summary: We are seeking a Supplier ... Support compliance with FDA 21 CFR Part 820 (QMSR) and ISO 13485 . * Prepare quality reports 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 ...
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 ...
Quick apply
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 ...
$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.
Contractor
This job post has expired 1 day ago. Applications are no longer accepted.
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