Quality Engineer 1 – Medical Device Manufacturing

About the role

The Quality Engineer 1 will support the development and production of Class I‑III medical devices at Viant’s Heredia site. The role involves quality planning, process validation, risk analysis, and supporting new product development.

Key responsibilities

• Prepare and update quality documents, Device Master Records and Device History Records.
• Review and approve manufacturing documentation created by Engineering.
• Support investigations of non‑conformities, complaints, calibrations, SCARs and environmental monitoring.
• Maintain CAPA and supplier files and follow up on corrective actions.
• Assist in qualification protocols (IQ, OQ, PQ, PPQ, TMV) and generate related reports.

Required profile

• Bachelor’s degree in Engineering, Pharmacy, Microbiology, Physics or Chemistry.
• 0‑1 year experience in a manufacturing environment.
• Bilingual English/Spanish with basic English reading and writing skills.
• Basic knowledge of statistical techniques and root‑cause analysis tools.

Required skills

• Minitab statistical software (plus).
• Basic descriptive statistics.
• Root‑cause analysis methodologies.
• Understanding of measurement and error theory.