Position Overview
Job Title: Quality Assurance Engineer – Design Controls
Job Description
The Quality Engineer – Design Controls ensures that all design and development activities for medical devices comply with applicable regulatory requirements, internal quality standards, and industry best practices. This role partners closely with R&D, Regulatory Affairs, Manufacturing, and Program Management to build robust Design History Files (DHFs), mitigate risk throughout the product lifecycle, and support successful design transfer into manufacturing. The position offers the opportunity to contribute to ongoing R&D and product development initiatives within a highly profitable medical device group, providing strong potential for career growth.
Responsibilities
+ Lead and support design control activities to ensure compliance with relevant medical device regulations, standards, and internal quality procedures.
+ Ensure complete and accurate documentation and traceability throughout a...