Ingeniero/a de Calidad – Dispositivos Médicos

About the role

We are looking for a Quality Engineer to support the development and production of Class I‑III medical devices at our Heredia site. The role combines on‑site work with occasional remote activities, providing quality engineering expertise across product design, manufacturing, and supplier management.

Key responsibilities

• Coordinate new process inspections and collaborate with design, production, and external vendors.
• Prepare and present quality metrics for management and operations reviews.
• Review drawings and tooling, recommending improvements for productivity, quality, and safety.
• Lead qualification and validation activities (IQ, OQ, PQ, TMV) in compliance with FDA regulations.
• Investigate audit non‑conformances, complaints, and CAPA actions.
• Develop risk management documentation, including Risk Management Plans, Reports, and Process FMEAs.
• Supervise Quality Inspectors/Technicians, assign tasks, and provide training.
• Act as internal auditor and support supplier audits, qualifications, and training programs.

Required profile

• Bachelor’s degree in Engineering, Pharmacy, Microbiology, Physics, Chemistry or related field.
• Advanced bilingual proficiency in English and Spanish (written and spoken).
• Knowledge of FDA regulations applicable to medical device manufacturing.

Required skills

• Quality Management Systems (QMS)
• FDA regulatory compliance (IQ, OQ, PQ, TMV)
• Risk Management and FMEA
• CAPA investigation and resolution
• Process validation and qualification
• Internal auditing
• Supplier quality management
• Quality metrics reporting