Quality Engineer 1 – Medical Devices

About the role

We are looking for a Quality Engineer 1 to support the development and production of Class I‑III medical devices at our Heredia site. The role involves quality planning, process validation, risk analysis and supporting new product development while ensuring compliance with regulatory standards.

Key responsibilities

• Prepare and update quality documentation linked to Device Master Records and Device History Records.
• Review and approve manufacturing documentation from Engineering to sustain production processes.
• Investigate non‑conformances, complaints, calibrations, SCARs and environmental monitoring, and follow up on corrective actions.
• Support qualification activities (IQ, OQ, PQ, PPQ, TMV) and compile data for reports.

Required profile

• Bachelor’s degree in Engineering, Pharmacy, Microbiology, Physics or Chemistry.
• 0‑1 year experience in a manufacturing environment, preferably medical devices.
• Bilingual English/Spanish with basic reading and writing proficiency in English.

Required skills

• Basic descriptive statistics and statistical techniques.
• Root cause analysis tools.
• Proficiency with Minitab statistical software.
• Understanding of measurement and error theory.
• Ability to read and interpret technical drawings.