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 guidelines. <...