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 combines hands‑on quality engineering, documentation, and cross‑functional collaboration to ensure compliance and continuous improvement.

Key responsibilities

• Prepare, update, and maintain quality documentation linked to Device Master Records and Device History Records.
• Review and approve manufacturing engineering documents to sustain production processes and quality systems.
• Support analysis, implementation, and improvement of manufacturing processes, tools, and supplier performance.
• Investigate and resolve non‑conformances, complaints, calibration issues, SCARs, and environmental monitoring findings.
• Maintain CAPA and supplier files, and follow up on corrective and preventive actions.
• Execute equipment qualifications (IQ, OQ, PQ, PPQ, TMV) and compile data for final reports.

Required profile

• Bachelor’s degree in Engineering, Pharmacy, Microbiology, Physics, Chemistry or related field.
• 0–1 year experience in a manufacturing environment, preferably medical‑device related.
• Bilingual English/Spanish with basic reading and writing proficiency in English.
• Basic knowledge of descriptive statistics and root‑cause analysis tools.

Required skills

• Proficiency with Minitab statistical software (preferred).
• Ability to apply basic descriptive statistical techniques.
• Experience with root‑cause analysis methodologies.
• Familiarity with CAPA processes and audit procedures.

What we offer

• Full‑time, Monday‑Friday schedule with potential remote flexibility.
• Opportunities for professional growth in the medical‑device industry.
• Collaborative, cross‑functional work environment.