Quality Engineer I - Exempt

Join our dynamic team in North Haven, CT, where you will have the opportunity to work on-site at least four days a week. This location offers a vibrant community and is a hub for innovation in healthcare technology.

Project Overview

Contribute to the New Product Development (NPD) Quality team, focusing on the development of Risk Management files and Design History files for new surgical products.

Team Composition

Be part of a collaborative team of 16 Quality Engineers, ranging from Principal to QEII, working together to ensure the highest quality standards.

Key Responsibilities

• Create and maintain Risk Management files for new products, including Preliminary Hazard Analysis (PHA) and Risk Analysis Chart (RAC) creation.


• Develop Design Failure Mode and Effects Criticality Analysis (DFMECA).


• Support Design Validation and Design Verification activities.


• Conduct Complaint Analysis, Pred...