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Capa Jobs in Seattle, WA (NOW HIRING)

Intellectt INC

Automated Inspection Technician

Bothell, WA · On-site

$24.25 - $32.25/hr

CAPA & Process Improvement * High-Speed Production Equipment Responsibilities: * Perform setup and challenge activities on automated inspection machines * Troubleshoot equipment issues during batch ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

This hybrid contract opportunity offers hands-on involvement with quality systems, CAPA investigations, supplier quality initiatives, and cross-functional process improvements in a fast-paced, highly ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

This hybrid contract opportunity offers hands-on involvement with quality systems, CAPA investigations, supplier quality initiatives, and cross-functional process improvements in a fast-paced, highly ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

This hybrid contract opportunity offers hands-on involvement with quality systems, CAPA investigations, supplier quality initiatives, and cross-functional process improvements in a fast-paced, highly ...

Immunome, Inc.

Director, Quality Operations

Bothell, WA · On-site

Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products. * Interact with manufacturing, clinical, or ...

OSI Systems, Inc

Sr. Manager Quality

Snoqualmie, WA · On-site

$165K - $185K/yr

Ensure substantial Quality Assurance employee ownership and completion of CAPA activities. * Manages conformity assessment audits of policies, procedures and quality systems to identify non ...

Quickparts Acquisition Inc

Quality Manager

Seattle, WA · On-site

$150K - $160K/yr

Own the CAPA system , ensuring root cause analysis rigor using 8D, Ishikawa, and 5-Why methodologies with timely closure Supplier & Customer Quality * Evaluate incoming materials, lead source ...

Quickparts Acquisition Inc

Quality Manager

Seattle, WA · On-site

$150K - $160K/yr

Own the CAPA system , ensuring root cause analysis rigor using 8D, Ishikawa, and 5-Why methodologies with timely closure Supplier & Customer Quality * Evaluate incoming materials, lead source ...

OSI Systems

Sr. Manager Quality

Snoqualmie, WA · On-site

Ensure substantial Quality Assurance employee ownership and completion of CAPA activities. * Manages conformity assessment audits of policies, procedures and quality systems to identify non ...

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How much do capa jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for capa in Seattle, WA is $45.64, according to ZipRecruiter salary data. Most workers in this role earn between $34.60 and $53.07 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of a CAPA specialist?

A CAPA specialist is responsible for investigating quality issues, identifying root causes, and implementing corrective and preventive actions to ensure ongoing compliance and product integrity. Their typical day involves reviewing nonconformance reports, collaborating with cross-functional teams, documenting findings, and tracking the progress of CAPA initiatives using specialized software. CAPA specialists also prepare reports for audits and may facilitate meetings to drive continuous improvement activities. This role often requires balancing multiple projects and deadlines in a regulated environment, making organizational and communication skills crucial for success.

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

To thrive as a CAPA (Corrective and Preventive Action) specialist, you need expertise in quality management systems, root cause analysis, and compliance with industry standards, typically backed by a degree in engineering, life sciences, or a related field. Familiarity with CAPA software, regulatory frameworks (such as ISO 13485 or FDA 21 CFR Part 820), and document control systems is essential. Strong analytical thinking, attention to detail, and effective communication skills are vital soft skills for this role. These skills ensure effective problem-solving and sustained compliance, which are essential for maintaining product quality and meeting regulatory requirements.

What is a CAPA?

A CAPA (Corrective and Preventive Action) job involves identifying, investigating, and resolving quality issues in industries like manufacturing, healthcare, and pharmaceuticals. CAPA professionals analyze root causes of defects or process failures and implement corrective actions to prevent recurrence. They ensure compliance with regulatory standards, document findings, and improve overall quality management systems. Their role is critical in maintaining product safety, efficiency, and regulatory adherence.

What are the most commonly searched types of Capa jobs in Seattle, WA? The most popular types of Capa jobs in Seattle, WA are:
What are popular job titles related to Capa jobs in Seattle, WA? For Capa jobs in Seattle, WA, the most frequently searched job titles are:
What job categories do people searching Capa jobs in Seattle, WA look for? The top searched job categories for Capa jobs in Seattle, WA are:
What cities near Seattle, WA are hiring for Capa jobs? Cities near Seattle, WA with the most Capa job openings:
Capa jobs near you
Infographic showing various Capa job openings in Seattle, WA as of August 2026, with employment types broken down into 86% Full Time, 4% Part Time, 1% Temporary, 8% Contract, and 1% Nights. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $94,931 per year, or $45.6 per hour.

Senior CAPA FDA Lead

Accord Technologies Inc.

Bothell, WA • On-site

Contractor

Re-posted 21 days ago

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