Quality Engineer - ISO 13485

Requirements: Bilingual (will need to translate an existing QMS structure into local Spanish language for implementation. On site. Fast self-starter, very tight timeline for implementation. Able to write gap-fill procedures as needed. Must be able to help implement a complaint process. Ultimately needs to ensure all steps are in place for successful ISO certification. Current State: The QMS is not currently ISO certified. However, an internal gap assessment has been completed against ISO 13485, and the client is awaiting the list of observations. There’s no need to build QMS processes from scratch—will be able to leverage and extend the existing QMS from another location. Organizational Structure: This facility reports into one of Ansell’s entities from an organizational perspective, though it is registered as a standalone business entity. Quality Team: The current team consists of two dedicated Quality professionals—a Quality Engineer and a Quality Technician. Operations: The site is focused exclusively on packaging and assembly, with no manufacturing activities. For example, it assembles multiple finished components into custom kits or packages them into final packaging configurations. Number of employees: ~60 people, 1 shift M-F (sometimes runs less than 5 days).

Location: Juarez, MX

Posted Date: 6/15/2025