Location
Miami, FL, United States
Posted
June 15, 2026
Job Description
Job Title: Quality Engineer – Design Controls (Medical Device)Position Overview
We are seeking a Quality Engineer with strong Design History File (DHF) experience to support medical device product development. This role partners cross-functionally with R&D, Regulatory, and Manufacturing to ensure robust design controls, complete DHF documentation, and compliance with FDA/ISO requirements throughout the product lifecycle.
This is a high-impact role within a growing medical device organization, with strong visibility across new product development programs.
Key Responsibilities
+ Lead and support design control activities in compliance with FDA, ISO 13485, and internal quality standards
+ Own and maintain Design History Files (DHF), ensuring completeness, traceability, and audit readiness
+ Ensure full traceability from user needs design inputs outputs verification validation design transfer
+ Partner with R&D to develop and review design docu...
We are seeking a Quality Engineer with strong Design History File (DHF) experience to support medical device product development. This role partners cross-functionally with R&D, Regulatory, and Manufacturing to ensure robust design controls, complete DHF documentation, and compliance with FDA/ISO requirements throughout the product lifecycle.
This is a high-impact role within a growing medical device organization, with strong visibility across new product development programs.
Key Responsibilities
+ Lead and support design control activities in compliance with FDA, ISO 13485, and internal quality standards
+ Own and maintain Design History Files (DHF), ensuring completeness, traceability, and audit readiness
+ Ensure full traceability from user needs design inputs outputs verification validation design transfer
+ Partner with R&D to develop and review design docu...