Gestor de Calidad Senior – ISO 13485 – Dispositivos Médicos

About the role

ElectroPlast, a Costa Rican manufacturer of medical devices operating under a free‑zone regime, is looking for a Senior Quality Manager to lead its Quality Management System. The role involves preparing the organization for external audits, driving continuous improvement, and fostering a genuine quality culture.

Key responsibilities

• Lead and maintain the ISO 13485 and ISO 9001 quality management system.
• Act as the lead auditor for ISO 13485 audits and coordinate with international auditors and regulators.
• Manage CAPA, NCR, FMEA, root‑cause analysis and risk management per ISO 14971.
• Develop and deliver training to embed quality practices across the company.
• Oversee documentation control, internal audits and corrective actions.

Required profile

• Bachelor’s degree in Industrial Engineering, Quality Engineering, Biomedical Engineering or related field.
• Minimum five years of experience in quality management systems and at least one year in the medical device industry.
• Advanced English (B2+/C1) for interaction with auditors and regulatory bodies.
• Proven experience as ISO 13485 lead auditor.

Required skills

• ISO 13485 implementation and auditing.
• ISO 9001 implementation.
• CAPA, NCR, FMEA, RCA, ISO 14971 risk management.

What we offer

• Leadership of the full Quality Management department reporting directly to the Operations Director.
• Work in a double‑certified ISO 13485 / ISO 9001 environment.
• Exposure to international audits and regulatory agencies.
• On‑site role, Monday‑Friday, based in Orotina, Alajuela, Costa Rica.