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Validation engineer
Job in
Broadview Heights, Cuyahoga County, Ohio, 44147, USA
Listed on 2025-12-13
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-13
Job specializations:
-
Engineering
Quality Engineering
Job Description & How to Apply Below
Validation Engineer – Katalyst CRO
Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards.
Roles & Responsibilities- Prepare test samples and fixtures for mechanical and functional testing.
- Execute tests and document results per Good Documentation Practices (GDP). Generate Test Reports for inclusion in the Design History File (DHF).
- Coordinate with cross‑functional teams to ensure timely completion of testing activities.
- Hands‑on experience with mechanical testing and data acquisition systems.
- Ability to interpret engineering drawings and specifications.
- Familiarity with ISO 13485 and FDA QSR requirements preferred.
- 2–4 years of experience required.
- Develop Test Protocols aligned with design verification plans and regulatory requirements.
Associate
Employment TypeContract
Job FunctionPharmaceutical Manufacturing
LocationBroadview Heights, OH
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