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Fda Inspector Jobs in Bothell, WA (NOW HIRING)

Accord Technologies Inc.

Senior CAPA FDA Lead

Bothell, WA · 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 ...

Apply Early

Systimmune

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Lead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response management * Lead internal audits and inspection readiness for CLIA/CAP and ...

Apply Early

SystImmune, Inc

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Lead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response management * Lead internal audits and inspection readiness for CLIA/CAP and ...

Bruker Corporation

QC Inspector

Bothell, WA · On-site

$41K - $66K/yr

Participates in FDA/ISO inspections and customer audits and maintain ongoing audit readiness * Perform other relevant duties as may be assigned by management * Act as Quality ambassador providing ...

Bruker

QC Inspector

Bothell, WA · On-site

$41K - $66K/yr

Participates in FDA/ISO inspections and customer audits and maintain ongoing audit readiness * Perform other relevant duties as may be assigned by management * Act as Quality ambassador providing ...

Bruker Corporation

QC Inspector

Bothell, WA

$41K - $66K/yr

Participates in FDA/ISO inspections and customer audits and maintain ongoing audit readiness * Perform other relevant duties as may be assigned by management * Act as Quality ambassador providing ...

UNAVAILABLE

QC Inspector

Bothell, WA

$41K - $66K/yr

Participates in FDA/ISO inspections and customer audits and maintain ongoing audit readiness * Perform other relevant duties as may be assigned by management * Act as Quality ambassador providing ...

Verathon, Inc.

Quality Inspector III

Bothell, WA · On-site

$24.03 - $31.75/hr

The Quality Inspector is responsible for supporting the Quality and Operations teams by performing ... FDA cGMP regulations desirable • Ability to lift 40 pounds Salary range - $24.03 - $31.75 ...

Verathon, Inc.

Quality Inspector III

Bothell, WA

$24.03 - $31.75/hr

The Quality Inspector is responsible for supporting the Quality and Operations teams by performing ... FDA cGMP regulations desirable Ability to lift 40 pounds Salary range - $24.03 - $31.75 ...

Verathon, Inc.

Quality Inspector III

Bothell, WA

$24.03 - $31.75/hr

The Quality Inspector is responsible for supporting the Quality and Operations teams by performing ... FDA cGMP regulations desirable • Ability to lift 40 pounds Salary range - $24.03 - $31.75 ...

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All JobsFda Inspector JobsFda Inspector Jobs in Bothell, WA

Fda Inspector information

See Bothell, WA salary details

$27.4K

$61.4K

$110.7K

How much do fda inspector jobs pay per year?

As of Jul 1, 2026, the average yearly pay for fda inspector in Bothell, WA is $61,416.00, according to ZipRecruiter salary data. Most workers in this role earn between $43,000.00 and $71,000.00 per year, depending on experience, location, and employer.

What type of inspectors make the most money?

Within the FDA inspection roles, senior-level inspectors such as Supervisory Food and Drug Inspectors or those with specialized expertise in areas like pharmaceuticals or biotechnology tend to earn higher salaries. Factors influencing pay include experience, certifications, and the complexity of inspections conducted, often requiring advanced knowledge of regulations and compliance standards.

What types of facilities or products do FDA Inspectors typically review, and what does a typical inspection process involve?

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.

What are the key skills and qualifications needed to thrive in the Fda Inspector position, and why are they important?

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.

What are the four types of FDA Inspections?

FDA inspectors conduct four main types of inspections: routine inspections to monitor compliance, for-cause inspections triggered by specific concerns or complaints, follow-up inspections to verify corrective actions, and pre-approval inspections for new drug or device applications. These inspections help ensure that facilities meet regulatory standards for safety and quality.

Is it hard to get a job at FDA?

Becoming an FDA inspector can be competitive due to strict qualification requirements, including relevant experience, education, and passing civil service exams. Candidates often need a background in science, public health, or regulatory fields, along with strong attention to detail and knowledge of FDA regulations. The hiring process can be lengthy and involves multiple steps such as interviews and background checks.

How do you become an FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in food safety, pharmaceuticals, or manufacturing. They must pass a written exam and a background check, and often complete training at the FDA's training center. Strong attention to detail, knowledge of regulatory standards, and good communication skills are essential for the role.

What does an FDA Inspector do?

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.

What job categories do people searching Fda Inspector jobs in Bothell, WA look for? The top searched job categories for Fda Inspector jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Fda Inspector jobs? Cities near Bothell, WA with the most Fda Inspector job openings:
Fda Inspector jobs near you
Senior CAPA FDA Lead

Senior CAPA FDA Lead

Accord Technologies Inc.

Bothell, WA • On-site

Contractor

Posted 13 days ago

Be an early applicant

Job description

Position : Senior CAPA FDA Lead
Location: Bothell, Washington
Visa: Any Visa
Position type: C2C

 
 
Job Description

Key Responsibilities
  • 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 as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
  • Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
  • Drive Health Hazard Evaluation (HHE) assessments for product quality issues, complaints, deviations, recalls, and field actions.
  • Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
  • Conduct gap assessments against FDA expectations and industry best practices.
  • Support mock audits, inspection simulations, and response preparation activities.
  • Ensure timely closure of audit observations, commitments, and remediation plans.
  • Mentor teams on FDA expectations, documentation standards, root cause analysis, and inspection behavior.
  • Support preparation and review of regulatory responses, including 483 responses and associated action plans where applicable.
     
Required Experience
  • 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
  • Strong hands-on experience in:
    • CAPA management systems
    • Root cause investigations
    • Health Hazard Evaluation (HHE)
    • FDA audit/inspection management
    • Regulatory compliance programs
  • Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
  • Demonstrated experience handling regulatory escalations, observations, and remediation programs.
  • Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
  • Experience working in cross-functional and high-pressure audit environments.
Preferred Qualifications
  • Experience handling FDA inspections involving critical observations or remediation programs.
  • Exposure to recalls, field actions, complaint handling, and product risk evaluations.
  • Certifications in Quality or Regulatory disciplines are preferred.
  • Strong executive communication and stakeholder management skills.
     
Key Skills
  • FDA Inspection Readiness
  • CAPA Effectiveness
  • Health Hazard Evaluation (HHE)
  • Regulatory Compliance
  • Root Cause Analysis
  • Risk Assessment
  • Audit Presentation & Defense
  • Quality Systems
  • Cross-functional Leadership
  • Executive Communication
Location: Bothell, Washington
Visa: Any Visa
Position type: C2C Contract

Job Title
Senior CAPA FDA Lead
Job Description
Key Responsibilities
  • 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 as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
  • Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
  • Drive Health Hazard Evaluation (HHE) assessments for product quality issues, complaints, deviations, recalls, and field actions.
  • Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
  • Conduct gap assessments against FDA expectations and industry best practices.
  • Support mock audits, inspection simulations, and response preparation activities.
  • Ensure timely closure of audit observations, commitments, and remediation plans.
  • Mentor teams on FDA expectations, documentation standards, root cause analysis, and inspection behavior.
  • Support preparation and review of regulatory responses, including 483 responses and associated action plans where applicable.
     
Required Experience
  • 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
  • Strong hands-on experience in:
    • CAPA management systems
    • Root cause investigations
    • Health Hazard Evaluation (HHE)
    • FDA audit/inspection management
    • Regulatory compliance programs
  • Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
  • Demonstrated experience handling regulatory escalations, observations, and remediation programs.
  • Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
  • Experience working in cross-functional and high-pressure audit environments.
Preferred Qualifications
  • Experience handling FDA inspections involving critical observations or remediation programs.
  • Exposure to recalls, field actions, complaint handling, and product risk evaluations.
  • Certifications in Quality or Regulatory disciplines are preferred.
  • Strong executive communication and stakeholder management skills.
     
Key Skills
  • FDA Inspection Readiness
  • CAPA Effectiveness
  • Health Hazard Evaluation (HHE)
  • Regulatory Compliance
  • Root Cause Analysis
  • Risk Assessment
  • Audit Presentation & Defense
  • Quality Systems
  • Cross-functional Leadership
  • Executive Communication