Medical Device Quality Systems & FDA Inspection Readiness Consultant Location: Atlanta/Duluth, Georgia area Work Arrangement: Onsite Duration: Immediate start through November 2026, with potential ...
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Medical Device Quality Systems & FDA Inspection Readiness Consultant Location: Atlanta/Duluth, Georgia area Work Arrangement: Onsite Duration: Immediate start through November 2026, with potential ...
Quick apply
Medical Device Quality Systems & FDA Inspection Readiness Consultant Location: Atlanta/Duluth, Georgia area Work Arrangement: Onsite Duration: Immediate start through November 2026, with potential ...
Bothell, WA ยท On-site
Lead FDA audit and inspection readiness activities across the business. * Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions. * Act ...
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Bothell, WA ยท On-site
Lead FDA audit and inspection readiness activities across the business. * Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions. * Act ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Quick apply
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Quick apply
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Pine Brook, NJ ยท On-site +1
FDA inspections, 483 responses and warning letters * Drug withdrawals and recalls * FDA importation and exportation rules * Veterinary medicine and veterinary compounding * Dietary supplements * FDA ...
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Pine Brook, NJ ยท On-site +1
FDA inspections, 483 responses and warning letters * Drug withdrawals and recalls * FDA importation and exportation rules * Veterinary medicine and veterinary compounding * Dietary supplements * FDA ...
Washington, DC ยท On-site +1
Office. Qualified candidates will have at least 5 years of experience as an FDA investigator or in a senior global quality role to assist the FDA team in responding to FDA inspections at ...
New
Washington, DC ยท On-site +1
Office. Qualified candidates will have at least 5 years of experience as an FDA investigator or in a senior global quality role to assist the FDA team in responding to FDA inspections at ...
New
Washington, DC ยท On-site +1
Office. Qualified candidates will have at least 5 years of experience as an FDA investigator or in a senior global quality role to assist the FDA team in responding to FDA inspections at ...
New
Washington, DC ยท On-site +1
Office. Qualified candidates will have at least 5 years of experience as an FDA investigator or in a senior global quality role to assist the FDA team in responding to FDA inspections at ...
New
Support remediation activities resulting from FDA inspection observations. * Assist with quality and regulatory record management and remediation. * Support implementation and integration of FDA QMSR ...
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Support remediation activities resulting from FDA inspection observations. * Assist with quality and regulatory record management and remediation. * Support implementation and integration of FDA QMSR ...
Washington, DC ยท On-site +1
Prepare clients for inspections, provide inspection support (remote and on-site) * Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other ...
Washington, DC ยท On-site +1
Prepare clients for inspections, provide inspection support (remote and on-site) * Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other ...
Washington, DC ยท On-site
Prepare clients for inspections, provide inspection support (remote and on-site) * Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other ...
Washington, DC ยท On-site
Prepare clients for inspections, provide inspection support (remote and on-site) * Provide technical support for remediation efforts in response to Form FDA 483s, Warning Letters, and other ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Quick apply
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Provide legal guidance during FDA inspections, investigations, and enforcement actions * Conduct legal research and analysis on FDA laws, regulations, and enforcement trends * Collaborate with ...
Provide legal guidance during FDA inspections, investigations, and enforcement actions * Conduct legal research and analysis on FDA laws, regulations, and enforcement trends * Collaborate with ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Complete annual training and certification to maintain FDA Commissioned Inspector status. * Attend regular program meetings and refresher training sessions to stay updated on federal and state ...
Washington, DC ยท On-site
$365K/yr
Provide legal guidance during FDA inspections, investigations, and enforcement actions * Conduct legal research and analysis on FDA laws, regulations, and enforcement trends * Collaborate with ...
Washington, DC ยท On-site
$365K/yr
Provide legal guidance during FDA inspections, investigations, and enforcement actions * Conduct legal research and analysis on FDA laws, regulations, and enforcement trends * Collaborate with ...
Monmouth Junction, NJ ยท On-site
Prepare sites for FDA inspections. * Manage quality agreements. * Support design transfer and validation. Cross-Functional Leadership: * Partner with RD, manufacturing, and operations. * Support ...
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Monmouth Junction, NJ ยท On-site
Prepare sites for FDA inspections. * Manage quality agreements. * Support design transfer and validation. Cross-Functional Leadership: * Partner with RD, manufacturing, and operations. * Support ...
Accompany an FDA-commissioned inspector to designated retail locations to assess compliance with tobacco sales regulations. * Attempt to purchase tobacco products while strictly adhering to FDA ...
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Accompany an FDA-commissioned inspector to designated retail locations to assess compliance with tobacco sales regulations. * Attempt to purchase tobacco products while strictly adhering to FDA ...
$24.5K - $31.3K
3% of jobs
$31.3K - $38K
16% of jobs
$39.7K is the 25th percentile. Wages below this are outliers.
$38K - $44.8K
23% of jobs
The median wage is $46.9K / yr.
$44.8K - $51.6K
27% of jobs
$55.9K is the 75th percentile. Wages above this are outliers.
$51.6K - $58.4K
10% of jobs
$58.4K - $65.1K
4% of jobs
$65.1K - $71.9K
5% of jobs
$71.9K - $78.7K
2% of jobs
$78.7K - $85.5K
2% of jobs
$85.5K - $92.2K
2% of jobs
$92.2K - $99K
5% of jobs
$24.5K
$54.9K
$99K
An FDA Inspector is responsible for ensuring that companies comply with federal regulations related to food, drugs, medical devices, and other products overseen by the U.S. Food and Drug Administration. They conduct inspections, review records, collect samples, and assess manufacturing practices to ensure public health and safety. Inspectors may also investigate complaints, issue compliance notices, and recommend enforcement actions if violations are found.
To thrive as an FDA Inspector, you need a solid background in science or public health, attention to detail, and thorough knowledge of regulatory standards, often supported by a relevant degree. Familiarity with inspection protocols, laboratory testing equipment, and digital reporting systems is commonly required, along with potential USDA or FDA certifications. Strong analytical thinking, effective communication, and integrity are important soft skills for this role. These competencies ensure accurate inspections, compliance with safety regulations, and clear reporting essential to public health and organizational accountability.
FDA Inspectors routinely examine a variety of facilities, such as food processing plants, pharmaceutical manufacturers, medical device companies, and cosmetic production sites, to ensure compliance with federal safety and quality regulations. A typical inspection involves reviewing operational procedures, examining production environments, sampling products, and interviewing staff to identify potential violations or risks. Inspectors often work onsite, sometimes with travel required to cover multiple locations within their region, and collaborate closely with facility management to explain findings and recommend corrective actions. This role offers the opportunity to make a significant impact on public health and provides clear advancement pathways into specialized inspection or supervisory roles within regulatory agencies.
Cities with the most Fda Inspector job openings:
The most popular types of Fda Inspector jobs are:
States with the most job openings for Fda Inspector jobs include:
The top searched job categories for Fda Inspector jobs are:

Atlanta, GA โข On-site
Full-time
Posted 4 days ago
Medical Device Quality Systems & FDA Inspection Readiness Consultant
Location: Atlanta/Duluth, Georgia area
Work Arrangement: Onsite
Duration: Immediate start through November 2026, with potential extension
Start: Immediate
Position Overview
We are seeking an experienced Medical Device Quality Systems Consultant to provide hands-on support for the startup of a new Class I medical device contract manufacturing operation.
The consultant will support Quality Management System (QMS) implementation, development of auditable quality and operational processes, system validation, and FDA inspection readiness. A key focus will be ensuring appropriate controls are established across production, warehousing, inventory, traceability, product hold/quarantine, release, and direct-to-consumer distribution activities.
The engagement will require both quality systems expertise and practical implementation support as the organization works toward regulatory and operational milestones in October and a planned November 1 go-live. The consultant may also provide training and ongoing Quality support following launch.
Key Responsibilities
Review the existing QMS and tailor requirements and processes for the new medical device manufacturing operation.
Support implementation of the QMS and ensure processes are operational, documented, and auditable.
Develop new quality and operational processes needed to support manufacturing and distribution activities.
Support validation of the warehouse management system and associated workflows.
Establish and/or assess controls for production, inventory management, product traceability, quarantine/hold, and product release.
Develop appropriate quality checks and controls for direct-to-consumer product shipments.
Assess Quality System and operational readiness for an anticipated FDA inspection.
Identify inspection-readiness gaps and support implementation of corrective actions before go-live.
Work directly with facility personnel to operationalize new procedures and quality controls.
Provide employee training and implementation support for new or revised processes, as needed.
Support the organization through its planned November 1 launch and provide ongoing Quality support following go-live, as needed.
Required Qualifications
Significant medical device Quality or Quality Systems experience.
Demonstrated experience implementing or adapting a QMS for medical device operations.
Strong knowledge of FDA medical device quality requirements and inspection readiness.
Experience developing and implementing auditable quality and operational processes.
Experience with warehouse, distribution, inventory, traceability, quarantine/hold, and product release controls.
Experience supporting computerized system validation or validation of warehouse/inventory management systems.
Ability to provide hands-on implementation support and work directly with site personnel.
Ability to work onsite in the Atlanta/Duluth, Georgia area.
Preferred Qualifications
Experience supporting startup or launch activities for a medical device manufacturing operation.
Experience with Class I medical devices.
Experience establishing quality controls for direct-to-consumer distribution.
Local to the Atlanta/Duluth, Georgia area.
Work Arrangement
This engagement requires onsite support in the Atlanta/Duluth, Georgia area. Local consultants are preferred to facilitate consistent onsite support.
Ideal Candidate
The ideal consultant is a hands-on Medical Device Quality Systems professional with experience taking QMS requirements from documented procedures through practical implementation. The consultant should be comfortable working across quality systems, warehouse and distribution controls, system validation, and FDA inspection readiness while helping a new manufacturing operation prepare for launch.
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Recruiting and staffing services
11 - 50 Employees
Westborough, MA, US
2007