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