Job Summary:

We are seeking an experienced CAPA Remediation Specialist to support the review, remediation, documentation, and closure of Corrective and Preventive Actions (CAPAs) within a regulated Quality Management System (QMS). The idóneo candidate will have strong expertise in medical device quality systems, root cause investigations, CAPA effectiveness, and regulatory compliance.

Key Responsibilities:

- Review and remediate open, overdue, and closed CAPA records for compliance and completeness.
- Evaluate investigations, root cause analyses, risk assessments, and corrective/preventive action plans.
- Apply root cause analysis tools such as 5-Why, Fishbone, and Fault Tree Analysis.
- Ensure CAPA actions are properly documented, traceable, measurable, and effective.
- Review supporting documentation, including SOPs, validation records, training records, and investigation reports.
- Verify linkage between CAPAs, complaints, nonconformances, deviations, audits, and other quality records.
- Document remediation activities within the electronic Quality Management System (eQMS).
- Support CAPA metrics, status reporting, audit readiness, and regulatory inspections.
- Collaborate with Quality, Regulatory, Engineering, Manufacturing,



and other cross-functional teams to complete remediation activities on schedule.

Required Qualifications:

- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- 10+ years of experience in Quality Assurance, Quality Systems, CAPA, or compliance within the medical device industry.
- Strong hands-on experience with CAPA investigations, remediation, and effectiveness verification.
- Solid understanding of FDA Quality System Regulations, ISO 13485, and applicable medical device regulations.
- Experience with electronic Quality Management Systems (eQMS).
- Excellent analytical, technical writing, documentation, and problem-solving skills.
- Strong communication skills with the ability to work independently and in cross-functional teams.

Preferred Qualifications:

- Experience supporting FDA inspections, regulatory remediation, or audit readiness initiatives.
- Experience with large-scale CAPA remediation programs and retrospective CAPA reviews.
- Knowledge of complaint handling, deviations, nonconformances, change control, and audit systems.
- Familiarity with ISO 14971 risk management principles.
- Experience preparing CAPA metrics, trend analysis, and management review reports.

📌 CAPA Remediation Specialist (México)
🏢 Intellectt
📍 México