Quality Systems Specialist - CAPA

• 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.

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