Quality Systems Specialist - CAPA

Merrimack Manufacturing; Manchester (NH); On-site; USD 65,000 - 95,000; Full time

Job summary

Merrimack Manufacturing is seeking a Quality System Specialist - CAPA to support and maintain the QMS in line with ISO 13485 and FDA QSR requirements. This role focuses on coordinating, tracking, and verifying CAPA and NC processes while collaborating across functions to ensure timely investigations, resolutions, and closures.

The position also supports internal audits, change control, management review preparation, and continuous improvement initiatives, providing essential documentation and

Qualifications

• Requires CAPA coordination, investigations, or quality systems experience.
• Knowledge of ISO 13485 and FDA QSR (21 CFR Part 820) preferred.
• Attention to detail and ability to manage multiple quality records.

Responsibilities

• Coordinate CAPA within the QMS to comply with ISO 13485 and FDA QSR.
• Maintain CAPA logs from initiation to closure with timeliness and accuracy.
• Monitor CAPA due dates and escalate overdue or high-risk items.
• Support updates to CAPA procedures, forms, and work instructions.

Skills

CAPA lifecycle

Root cause analysis

Documentation

Cross-functional

Data analysis

MS Office

QMS systems

Education

Associate or Bachelor's in Quality/Engineering/Life Sciences

Tools

Electronic QMS systems

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.

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 elevate 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 escalated 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