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Quality Lead: Assay & Specs
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-08-26
Listing for:
QuidelOrtho
Full Time
position Listed on 2026-08-26
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Quidel Ortho seeks a Quality Lead, Requirements and Specifications Management (Assay) to define and own the end-to-end requirements framework across a portfolio of assay‑based medical devices. You will partner with R&D, Regulatory Affairs, Manufacturing, and Product Management to embed quality throughout the product lifecycle.
Onsite at major sites, you will drive process standardization, compliance with ISO 13485, FDA 21 CFR 820, and IVDR, and lead continuous improvement initiatives to support
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