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Capa Manager Jobs in Seattle, WA (NOW HIRING)

GenScript/ProBio

Manager of Quality Assurance

Redmond, WA · On-site

$100K - $120K/yr

Expert knowledge of quality risk assessment, CAPA management, and change control methodologies within an RUO or ISO-certified manufacturing environment. * Proven track record in establishing or ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within ...

System One

Senior Quality Assurance Engineer

Redmond, WA · Remote

$65 - $73/hr

Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within ...

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 ...

Quickparts Acquisition Inc

Quality Manager

Seattle, WA · On-site

$150K - $160K/yr

Quality Manager - Additive Manufacturing Division Seattle, WA | Reports to Global Director of ... Own the CAPA system , ensuring root cause analysis rigor using 8D, Ishikawa, and 5-Why ...

Quickparts Acquisition Inc

Quality Manager

Seattle, WA · On-site

$150K - $160K/yr

Quality Manager - Additive Manufacturing Division Seattle, WA | Reports to Global Director of ... Own the CAPA system , ensuring root cause analysis rigor using 8D, Ishikawa, and 5-Why ...

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 ...

Mila

FSQA Manager

Sumner, WA · On-site

$115K - $140K/yr

The FSQA Manager will lead the plant FSQA team and partner closely with Operations, Sanitation ... Lead RCA/CAPA processes and ensure corrective actions are documented, verified, and sustained.

SystImmune, Inc

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

Manage CAPA, deviations, change control, and document control systems * Ensure training compliance and documentation across both functional areas * Support assay validation, method transfer, and fit ...

Helion Energy

Manager, Quality

Everett, WA · On-site

$182K - $214K/yr

Own quality execution across the hardware lifecycle, including nonconformance management, MRB, CAPA, supplier quality, root cause analysis, and continuous improvement * Partner with Engineering ...

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Capa Manager information

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How much do capa manager jobs pay per hour?

As of Aug 5, 2026, the average hourly pay for capa manager in Seattle, WA is $43.50, according to ZipRecruiter salary data. Most workers in this role earn between $33.04 and $51.25 per hour, depending on experience, location, and employer.

What does a CAPA manager do?

A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.

What are some common challenges a CAPA manager faces, and how are they typically addressed?

One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.

What are the key skills and qualifications needed to thrive as a CAPA manager?

To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

What are popular job titles related to Capa Manager jobs in Seattle, WA? For Capa Manager jobs in Seattle, WA, the most frequently searched job titles are:
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Capa Manager jobs near you

Senior CAPA FDA Lead

Accord Technologies Inc.

Bothell, WA • On-site

Contractor

Re-posted 19 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