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 adecuado 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