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Capa Specialist Jobs (NOW HIRING)

Symmetrio

Senior Quality Assurance Specialist

Richland, WA · On-site

$86K - $118K/yr

The Senior Quality Assurance Specialist will manage nonconformance and CAPA activities, support internal and external audits, monitor quality performance indicators, and help strengthen the ...

Nidec Motor

Role Overview The Quality Assurance Specialist owns one or more defined quality system processes or workstreams (e.g., document control, CAPA coordination, audit support, training compliance). The ...

Nidec Corporation

The Quality Assurance Specialist is an intermediate professional role responsible for independently ... Nonconformance & CAPA Coordination Independently document, track, and coordinate nonconformances ...

Symmetrio

Senior Quality Assurance Specialist

Richland, WA · On-site

$86K - $118K/yr

The Senior Quality Assurance Specialist will manage nonconformance and CAPA activities, support internal and external audits, monitor quality performance indicators, and help strengthen the ...

PTS Diagnostics

Compliance Specialist

Whitestown, IN · On-site

SUMMARY The Compliance Specialist works with site process owners, CAPA assignees, and QA Reps to effectively manage implementation of corrective and preventive actions in a timely manner. They are ...

Turbett Surgical

The Quality Systems Specialist will be responsible for administering key quality system processes ... CAPA, Nonconformance, and Change Control * Administer Corrective and Preventive Action (CAPA ...

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Capa Specialist information

What is a CAPA Specialist?

A CAPA (Corrective and Preventive Action) Specialist is responsible for managing and overseeing quality improvement processes within an organization, especially in regulated industries like pharmaceuticals, medical devices, and manufacturing. They investigate root causes of defects or non-conformities, implement corrective actions to address issues, and develop preventive measures to ensure compliance with industry standards and regulations. CAPA Specialists work closely with cross-functional teams to track and document quality improvements, ensuring continuous process enhancements. Their role is critical for maintaining product quality, regulatory compliance, and customer satisfaction.

What skills and qualifications are needed to thrive as a CAPA Specialist?

To thrive as a CAPA Specialist, you'll need a solid understanding of quality management principles, root cause analysis, and regulatory compliance, often supported by a degree in life sciences or a related technical field. Familiarity with CAPA (Corrective and Preventive Action) management systems, quality management software (such as TrackWise or MasterControl), and relevant certifications like Six Sigma or ISO 9001 are highly beneficial. Strong organizational, analytical, and communication skills, combined with attention to detail and the ability to collaborate across multiple departments, will help you excel in this role. These competencies are crucial for ensuring consistent process improvements and maintaining compliance within regulated industries such as pharmaceuticals, medical devices, or manufacturing.

What does a typical workday look like for a CAPA Specialist?

A typical workday for a CAPA Specialist involves investigating quality issues, conducting root cause analyses, and documenting findings within the CAPA management system. You'll coordinate closely with production, quality assurance, and regulatory teams to implement corrective and preventive actions and track their effectiveness over time. Expect to attend cross-functional meetings, review compliance documentation, and communicate status updates to management regularly. Your role is integral to ensuring that quality issues are properly addressed and that the organization meets both internal and external regulatory standards.

What does a Capa Specialist do?

A CAPA (Corrective and Preventive Action) Specialist is responsible for investigating quality issues, implementing corrective actions, and ensuring compliance with regulatory standards such as FDA or ISO. They analyze root causes of deviations, document findings, and collaborate with cross-functional teams to improve processes and prevent recurrence.
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Infographic showing various Capa Specialist job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 74% Full Time, 23% Part Time, and 2% Contract. Highlights an 85% Physical, 2% Hybrid, and 13% Remote job distribution.

Senior Quality Assurance Specialist

Richland, WA • On-site

Symmetrio
See more jobs at Symmetrioexternal

$86K - $118K/yr

Full-time

Re-posted 21 days ago

Job description

Symmetrio is recruiting a Senior Quality Assurance Specialist for a growing medical device company in Richland, Washington.
This position will provide quality oversight across the design, manufacturing, testing, and release of regulated medical devices. The Senior Quality Assurance Specialist will manage nonconformance and CAPA activities, support internal and external audits, monitor quality performance indicators, and help strengthen the organization's quality management system.
Responsibilities
  • Serve as the primary quality contact for manufacturing-related nonconformance and CAPA activities.
  • Review investigations for appropriate problem statements, root-cause analysis, corrections, and corrective or preventive actions.
  • Maintain NC and CAPA records within the electronic quality management system.
  • Ensure compliance with FDA 21 CFR requirements, ISO 13485, MDSAP, and other applicable standards.
  • Track quality performance indicators and present findings to management and cross-functional stakeholders.
  • Develop and conduct internal process audits.
  • Support notified-body audits and FDA inspections as a quality subject-matter expert.
  • Review and approve validation protocols, calibration records, analytical reports, and equipment maintenance records.
  • Monitor process controls, supplier quality, and product conformity.
  • Develop and improve manufacturing quality and compliance processes.
  • Provide quality-system training and support to team members.
  • Lead the resolution of quality issues involving manufacturing, operations, and support teams.
  • Perform additional quality-related responsibilities as assigned.

Requirements
  • Bachelor's degree in life sciences, engineering, or a related field, or an equivalent combination of education and experience.
  • At least eight years of quality assurance experience.
  • Experience within the medical device or pharmaceutical industry.
  • Working knowledge of FDA 21 CFR requirements, ISO 13485, and MDSAP.
  • Good Manufacturing Practices certification.
  • Experience managing nonconformance investigations and CAPA processes.
  • Strong knowledge of quality systems, manufacturing controls, and regulatory compliance.
  • Experience supporting internal audits, regulatory inspections, or notified-body audits.
  • Strong root-cause analysis, problem-solving, and process-improvement skills.
  • Excellent documentation, organization, and attention to detail.
  • Ability to interpret standard operating procedures and work instructions.
  • Strong written and verbal communication skills.
  • Ability to work effectively with cross-functional teams and manage multiple deadlines.
  • Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
  • Experience working in a radiologically controlled environment is preferred.
  • Ability to work a flexible schedule and travel as needed.
  • Ability to successfully complete required background and drug screenings.

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