Quality Manager – ISO 13485, Medical Devices

About the role

We are looking for a proactive Quality Manager to lead our Quality Management System (QMS) for medical devices in Orotina, Alajuela. The role ensures compliance with ISO 13485, ISO 9001 and ISO 14971, prepares the organization for audits and drives continuous improvement across processes.

Key responsibilities

• Lead and maintain the Quality Management System.
• Plan and coordinate internal, external, and regulatory audits.
• Manage CAPAs, NCRs, root‑cause analysis, and FMEA/risk management.
• Drive continuous improvement and process optimisation initiatives.
• Coordinate the Quality Management team and its activities.
• Ensure compliance with applicable legal, regulatory and quality requirements.
• Promote digitalisation and automation of quality documentation and processes.

Required profile

• Bachelor’s degree in Industrial Engineering, Quality Engineering, Biomedical Engineering, Business Administration or a related field.
• 5+ years of experience in Quality Management Systems.
• At least 1 year of experience in the medical device industry.
• Advanced English (B2+/C1) – mandatory.
• ISO 13485 Lead Auditor certification is a plus.
• Knowledge of Lean Manufacturing, 5S, digital tools and AI is a plus.

Required skills

• ISO 13485, ISO 9001, ISO 14971 standards.
• CAPA, NCR management.
• Root‑cause analysis, FMEA, risk management.
• Audit planning and execution.
• 5 Why and Ishikawa analysis.
• Advanced Microsoft Office.
• Lean Manufacturing and 5S methodologies.
• Digital tools and AI applications for quality.