Ingeniero de Validacion II (Calidad)

BEPC is looking for a qualified candidate to support validation activities within a regulated medical device manufacturing environment. This role is ideal for an engineering professional with experience in IQ/OQ validation, quality systems, and compliance with FDA, ISO 13485, and GMP requirements.

KEY RESPONSIBILITIES

• Provide technical engineering support for validation activities in regulated medical device manufacturing environments, including compliance with FDA, ISO 13485, and GMP requirements.
• Write and execute Installation Qualification (IQ) protocols and collect, analyze, and document data to support validation completion reports.
• Write and execute Operational Qualification (OQ) protocols, ensuring validation evidence meets quality and regulatory standards applicable to the medical industry.
• Support the execution of experiments during the pre‑validation phase, following risk‑based approaches and quality guidelin...