💼 Full-Time Position

Quality Engineer

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Katalyst Healthcares & Life Sciences
📍 Broadview Heights, Ohio, United States
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Location
Broadview Heights, Ohio, United States
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Posted
May 13, 2026
⏰
Type
Full-Time
🎯

Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.

Job Description

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 ...