Ingeniero de Calidad II – Tercer Turno

About the role

Under general supervision, the Quality Engineer II will support new and sustaining product and process teams to develop quality‑engineered systems for medical devices. The role involves leading design verification tests, process validations and ensuring compliance with FDA, ISO 13485 and other global regulations.

Key responsibilities

• Assist in new product development, sustaining and supply‑chain quality projects, including writing validation protocols and reports.
• Use statistical tools (Six Sigma, SPC, DOE) to analyze data, make acceptance decisions and improve process capability.
• Support design control, ensure products meet European MDR requirements and facilitate transfer to manufacturing.
• Lead vendor audits, support Supplier Quality, and manage NC, CAPA, internal audit and training activities.

Required profile

• Bachelor’s degree in a related field with 2–4 years of quality or manufacturing experience in a regulated industry.
• Knowledge of GMP, QSR, design control, verification and validation methodologies.
• Strong problem‑solving, verbal and written communication skills.

Required skills

• Six Sigma methodology
• Statistical Process Control (SPC) and Design of Experiments (DOE)
• GD&T concepts
• ASQ certification (preferred)