Quality Engineer

Katalyst Healthcares &amp; Life Sciences • Broadview Heights, Ohio, United States

📍 Location

Broadview Heights, Ohio

⏰ Job Type

Full-time

📅 Posted

May 13, 2026

About the Role

                                     Job Summary:          

               The Quality Engineer (Life Sciences) will support design control and quality activities for regulated medical device products.           

               The role involves executing design verification and validation, managing risk and change processes, and maintaining technical documentation in compliance with ISO and FDA regulations, while collaborating with cross-functional teams throughout the product lifecycle.          

               Roles & Responsibilities:          

               Lead DHF/DMR/DMR build activities in adherence to ISO 13485 and FDA 21 CFR Part 820 design control requirements.          

               Execute Design Verification and Validation (DVV) protocols, including test planning, execution, and reporting.          

               Manage ...

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