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 and FDA CFR Part design control requirements.
Execute Design Verification and Validation (DVV) protocols, including test planning, execution, and reporting.
Manage change management processes in compliance with ISO risk management and internal quality procedures.
Coordinate project activities across Quality, Regulatory, Manufacturing, and Supply Chain teams.
Create and maintain technical documentation i...
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Job Details
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Location
Broadview Heights, Ohio
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Job Type
Full-time
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Category
Engineers
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Posted Date
June 19, 2026
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Application Deadline
July 29, 2026