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Katalyst Healthcares & Life Sciences | Broadview Heights, Ohio, United States | Posted May 13, 2026
Position Overview
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 ...