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Capa Quality System Analyst Jobs (NOW HIRING)

Tosoh Bioscience, Inc.

... system experience required. * Understanding of quality concepts such as: cost of quality, analytical metrics, statistics and trending, quality planning, validation, CAPA and problem solving

Cooper Companies

Senior Global CAPA Engineer

Trumbull, CT · On-site

$86K - $117K/yr

Recommend process improvements that enhance CAPA effectiveness and quality system maturity. Coach CAPA owners and cross-functional teams on root cause analysis, investigation methodologies ...

Jobless

Identify opportunities for quality system and process improvement through CAPA data analysis. * Coordinate product recalls, advisory notices, field actions, and other post-market actions in ...

BioTalent

Quality System Specialist

Tustin, CA · On-site

$42.69 - $53.36/hr

... CAPA authoring, review, and approval activities ✔ Prepare and review SOPs, forms, batch ... Analysis • Impact Assessments • Inspection Readiness • Controlled Documents • Quality ...

Unigen

Quality System Specialist

Newark, CA · On-site

$78K - $88K/yr

Quality System Specialist Job Function: Quality Department Report to: Senior Quality Assurance ... Experience with internal/external audits and CAPA processes. * Strong analytical, organizational ...

Plastic Products Co.

Quality Coordinator

Lindstrom, MN · On-site

$22 - $27/hr

Quality Support (PPAP, FAIs, NCM, CAPA, Quality Alerts, Pictures) * Must have ISO 9001 quality system and blueprint reading experience. * Computer experience necessary - helpful to have experience in ...

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How much do capa quality system analyst jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for capa quality system analyst in the United States is $32.41, according to ZipRecruiter salary data. Most workers in this role earn between $24.28 and $37.02 per hour, depending on experience, location, and employer.

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Infographic showing various Capa Quality System Analyst job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution, with an average salary of $67,422 per year, or $32.4 per hour.

Quality Systems Specialist - CAPA

Manchester, NH • On-site

Merrimack Manufacturing
Industrial Machinery Manufacturing • 51 - 200 employees
Learn more about Merrimack Manufacturingexternal

Full-time

Posted 17 days ago

Job description

Position Summary
The Quality System Specialist - CAPA is responsible for supporting and maintaining the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements for medical device operations. This role is primarily focused on the coordination, tracking, reporting, and effectiveness monitoring of Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes.
The position works cross-functionally to ensure timely investigation, resolution, and closure of quality events while supporting overall QMS compliance activities including internal audits, complaint support, change control, management review preparation, and continuous improvement initiatives.
Key Responsibilities
CAPA System Coordination & Ownership
  • Coordinate and manage the CAPA process within the QMS to ensure compliance with ISO 13485, FDA QSR (21 CFR Part 820), and internal procedures and applicable regulatory requirements.
  • Maintain CAPA log integrity tracking CAPA records from initiation through closure, ensuring timeliness, accuracy, and completeness.
  • Monitor CAPA due dates and escalate overdue or high-risk items as needed.
  • Maintain accurate and complete CAPA records within the QMS system.
  • Support updates to CAPA-related procedures, forms, and work instructions.
  • Directly execute CAPA activities from investigation through execution of corrective actions. Execute CAPA effectiveness verification when necessary.

Root Cause Analysis & Effectiveness
  • Support cross-functional teams in performing structured root cause analysis (e.g., 5-Why, Fishbone, fault tree analysis).
  • Ensure corrective and preventive actions are clearly defined, implemented, and verified for effectiveness.
  • Track and document effectiveness checks and ensure closure criteria are met.
  • Identify trends across CAPA data and escalate recurring systemic issues.

Nonconformance (NC) Support
  • Support evaluation of Nonconformance (NC) records for potential CAPA initiation.
  • Ensure proper linkage between NCs and CAPAs when systemic issues are identified.
  • Assist in reviewing NC records for completeness and consistency from initiation to closure.
  • Initiates and documents NCs to ensure quality system issues are properly recorded, investigated, and resolved.
Change Control Support
  • Contribute to change control activities by assessing quality system impact and supporting implementation tracking.
  • Ensure supporting documentation and approvals are maintained appropriately.
Management Review & Metrics
  • Prepare CAPA KPIs, dashboards, and trend reports for management review.
  • Provide analysis on CAPA aging, closure rates, effectiveness, and recurrence trends.
  • Support quality system performance reporting and data visualization.
General QMS Support
  • Support document control, training compliance, and other quality system activities as needed.
  • Participate in continuous improvement and quality compliance initiatives.
  • Provide operational and administrative support to the QMS team.
  • Provide guidance on Good Documentation and Manufacturing Practices to the team as needed.
  • Support internal and external audits as needed.
Qualifications
Education & Experience
  • Associate or Bachelor's degree in Quality, Engineering, Life Sciences, or related field preferred.
  • 2-5 years of experience in Quality Systems, Quality Assurance, or regulated industry (medical device preferred).
  • Direct experience in CAPA coordination, investigations, or quality systems strongly preferred.
  • Working knowledge of ISO 13485 and FDA QSR (21 CFR Part 820).
Skills & Competencies
  • Strong understanding of CAPA lifecycle in a regulated environment.
  • Experience with root cause analysis and structured problem-solving tools.
  • Strong organizational skills and ability to manage multiple quality records simultaneously.
  • High attention to detail with strong documentation and follow-through discipline.
  • Ability to work cross-functionally and drive accountability for quality actions.
  • Analytical skills with ability to interpret quality trends and data.
  • Proficiency in Microsoft Office and electronic QMS systems.
  • Strong written and verbal communication skills.
Preferred Certifications
  • ISO 13485 Internal Auditor certification (not required for this role but beneficial).
  • ASQ certifications (CQIA, CQA, or CQE) a plus.

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