More jobs:
Quality Lead, Assay & Specifications
Job in
City of Rochester, Rochester, Monroe County, New York, 14602, USA
Listed on 2026-07-13
Listing for:
Ortho Clinical Diagnostics
Full Time
position Listed on 2026-07-13
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Location: City of Rochester
Quidel Ortho in Rochester, NY, seeks a Quality Lead, Requirements and Specifications Management (Assay) to drive end-to-end quality specifications for assay-based medical devices. This global role is onsite in Rochester, NY, within GQ&C and reports to senior leadership.
You will define, own, and continuously improve the requirements framework across the product lifecycle, collaborating with Manufacturing, R&D, Regulatory Affairs, and Supply Chain to ensure compliance with ISO
13485, 21 CFR 820,
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