Quality Systems Specialist-CAPA
Full-time
Merrimack Manufacturing
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
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.
- 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.
- 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.
- Contribute to change control activities by assessing quality system impact and supporting implementation tracking.
- Ensure supporting documentation and approvals are maintained appropriately.
- 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.
- 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.
- 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).
- 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.
- ISO 13485 Internal Auditor certification (not required for this role but beneficial).
- ASQ certifications (CQIA, CQA, or CQE) a plus.
Vacancy posted more than 2 months ago
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